Aquestive News - LARVOL Sigma

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||||||||||  Anaphylm (epinephrine) / Aquestive, epinephrine (AQST-108) / Aquestive
Trial completion:  Pharmacokinetics Study of DESF in Adults with Oral Allergy Syndrome (clinicaltrials.gov) -  Nov 5, 2024
P2, N=36, Completed,  Sponsor: Aquestive Therapeutics
Recruiting --> Completed

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Safety and Efficacy of Sublingual Apomorphine in Parkinson's Patients with or without Concomitant Dopamine Agonists Use (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1014;
Objective: This post-hoc analysis of Study CTH-301 aimed to assess the safety and efficacy of apomorphine sublingual film (SL-APO) in patients with Parkinson's disease with or without concurrent dopamine agonists (DA) use at baseline... While SL-APO was found to be better tolerated in DA users, it demonstrated efficacy in both DA and non-DA users.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Oropharyngeal Adverse Events in Parkinson's Patients with Motor Fluctuations Treated with Apomorphine Sublingual Film (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1013;
While SL-APO was found to be better tolerated in DA users, it demonstrated efficacy in both DA and non-DA users. Oropharyngeal TEAEs, including those leading to discontinuation, were mostly mild or moderate and predominantly occurred within the first few months of SL-APO initiation.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Baseline Variables Associated with Apomorphine Sublingual Film Retention (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1012;
Levodopa dose and intakes, morning akinesia, previous SL-APO exposure and concomitant dopamine agonists use might influence retention. These results may help identify patients more likely to remain on SL-APO over the long term.

||||||||||  Anaphylm (epinephrine) / Aquestive, epinephrine (AQST-108) / Aquestive
New P2 trial:  Pharmacokinetics Study of DESF in Adults with Oral Allergy Syndrome (clinicaltrials.gov) -  Jul 29, 2024
P2, N=36, Recruiting,  Sponsor: Aquestive Therapeutics

|||||||||| Clinical, Journal: Comparison Table: Some oral antiseizure medications. (Pubmed Central) - Jul 29, 2024
These results may help identify patients more likely to remain on SL-APO over the long term. No abstract available

|||||||||| Review, Journal: Drugs for epilepsy. (Pubmed Central) - Jul 29, 2024
No abstract available No abstract available

|||||||||| Review, Journal: Assessing the efficacy of amyotrophic lateral sclerosis drugs in slowing disease progression: A literature review. (Pubmed Central) - Jul 11, 2024
These FDA-sanctioned treatments are Qalsody, Relyvrio, Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta...However, despite these advancements in pharmaceutical interventions, finding a definitive cure for ALS remains a significant challenge. Continuous investigation into ALS pathophysiology and therapeutic avenues remains imperative, necessitating further research collaborations and innovative approaches to unravel the complex mechanisms underlying this debilitating condition.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Oropharyngeal adverse events in Parkinson (B3) - Jul 2, 2024 - Abstract #EAN2024EAN_2806;
Continuous investigation into ALS pathophysiology and therapeutic avenues remains imperative, necessitating further research collaborations and innovative approaches to unravel the complex mechanisms underlying this debilitating condition. Oropharyngeal TEAEs, including those leading to discontinuation, were mostly mild or moderate and predominantly occurred within the first few months of SL-APO initiation.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Baseline variables associated with apomorphine sublingual film retention (B3) - Jul 2, 2024 - Abstract #EAN2024EAN_2798;
Levodopa dose and intakes, morning akinesia, previous SL-APO exposure and concomitant dopamine agonist use might influence retention. These results may help identify patients more likely to remain on SL-APO over the long term.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Safety and efficacy of sublingual apomorphine in Parkinson (B4) - Jul 2, 2024 - Abstract #EAN2024EAN_1115;
Background and Aims: In Study CTH- 301, apomorphine sublingual film (SL- APO) was generally well tolerated and efficacious over the long term as treatment for OFF- episodes in patients with Parkinson ' s disease... While SL- APO was found to be better tolerated in DA users, it demonstrated efficacy in both DA and non- DA users.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Clinical, Journal: Clinical trial evaluating apomorphine oromucosal solution in Parkinson's disease patients. (Pubmed Central) - May 7, 2024
This two-part clinical study evaluated the safety, tolerability, pharmacokinetics (PK), and dose proportionality of a novel apomorphine hydrochloride oromucosal solution, as well as its relative bioavailability to subcutaneous apomorphine injection and apomorphine sublingual film...This was comparable to exposure reached after 2?mg subcutaneous apomorphine and approximately half of the exposure observed with 30?mg sublingual apomorphine. In summary, clinically relevant plasma concentrations could be reached in PD patients without tolerability issues.

|||||||||| diazepam / Generic mfg.
Crossover Study Evaluating the Effect of Seizures on the Absorption of Diazepam from a Buccal Film Formulation in Children with Epilepsy (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3244;
Likewise, the speed of diazepam absorption is not affected by dosing DBF either during or between seizures. DBF provides a convenient way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Journal: Apomorphine Sublingual Film Compared with Subcutaneous Apomorphine for OFF Episodes in Parkinson's Disease: An Open-Label, Randomized, Crossover Study. (Pubmed Central) - Nov 19, 2023
DBF provides a convenient way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children. Patients reported overall preference for and greater satisfaction with SL-APO over SC-APO.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Journal: Feasibility of home dose optimization of apomorphine sublingual film in Parkinson's disease patients with OFF episodes: results from the dose-optimization phase of an open-label, randomized crossover study. (Pubmed Central) - Nov 13, 2023
P3
After the first clinic dose, home dose optimization of SL-APO appears feasible in patients with PD and OFF episodes, with most patients identifying their optimal SL-APO dose at home. This study is registered with EudraCT (2016-003456-7): Clinical Trials register - Search for eudract_number:2016-003456-70.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Journal: Importance of time to ON versus wearing OFF in total daily OFF time experienced by patients with Parkinson's disease. (Pubmed Central) - Sep 11, 2023
However, the literature describing approved treatments for PD that has focused on delays in time to ON is sparse and suggests this type of OFF may comprise more than twice the amount of total daily OFF time as wearing OFF. Here, we advocate for the importance of measuring and adequately addressing delays in time to ON and build support for the consistent inclusion of the time to ON measurement in future clinical trials.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Apomorphine sublingual film for OFF episodes in PD: Impact on orthostatic hypotension during dose-optimization () - Aug 30, 2023 - Abstract #MDSCongress2023MDS_Congress_1407;
Here, we advocate for the importance of measuring and adequately addressing delays in time to ON and build support for the consistent inclusion of the time to ON measurement in future clinical trials. Overall, SL-APO did not affect general BP readings nor the frequency of OH as assessed by those readings during dose-optimization at in-clinic visits (co-occurring with or without reported OH-related TEAEs).

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Clinic versus home dose optimization of apomorphine sublingual film in Parkinson (C1 M0, Ground floor) - Aug 30, 2023 - Abstract #MDSCongress2023MDS_Congress_1404;
Overall, SL-APO did not affect general BP readings nor the frequency of OH as assessed by those readings during dose-optimization at in-clinic visits (co-occurring with or without reported OH-related TEAEs). After initiation in clinic, data from the pivotal and crossover studies suggest that the safety profile of SL-APO home dose optimization is comparable to clinic dose optimization.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Journal: Dose Optimization of Apomorphine Sublingual Film for OFF Episodes in Parkinson's Disease: Is the Prophylactic Use of an Antiemetic Necessary? (Pubmed Central) - May 16, 2023
After initiation in clinic, data from the pivotal and crossover studies suggest that the safety profile of SL-APO home dose optimization is comparable to clinic dose optimization. Prophylactic treatment with an antiemetic is not necessary for most patients who initiate SL-APO for the treatment of OFF episodes in PD.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Apomorphine Sublingual Film for OFF episodes in PD: Impact on Orthostatic Hypotension during Dose-Optimization (B3) - Apr 21, 2023 - Abstract #EAN2023EAN_1946;

|||||||||| epinephrine (AQST-108) / Aquestive
Comparison of the Pharmacokinetic and Pharmacodynamic profiles of epinephrine delivered by a sublingually absorbed film (DESF), versus 0.3 mg administered by a standard IM injection or the EpiPen (Convention Center, Lobby Level, Hall 2) - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1800;
Prophylactic treatment with an antiemetic is not necessary for most patients who initiate SL-APO for the treatment of OFF episodes in PD. DESF provides a unique and distinctly attractive PK profile relative to 0.3 mg injectable IM epinephrine, with a faster median Tmax and higher early dose partial AUC

|||||||||| epinephrine (AQST-108) / Aquestive
Pharmacokinetics of epinephrine sublingual film following three different administration procedures (Convention Center, Lobby Level, Hall 2) - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1687;
Holding saliva during administration enhanced early exposure. Not holding saliva still provides clinically meaningful levels but increase the risk of lower absorption relative to the other procedures.

|||||||||| epinephrine (AQST-108) / Aquestive
Impact of food exposure on the pharmacokinetics of epinephrine sublingual film (Convention Center, Lobby Level, Hall 2) - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1682;
Tmax, Cmax, early partial AUCs, and pharmacodynamic responses were consistent regardless of the presence of food residue. This provides reassurance that the product absorption would not be impaired in

|||||||||| epinephrine (AQST-108) / Aquestive
Pharmacokinetics and pharmacodynamics of epinephrine sublingual film versus intra-muscular epinephrine (Convention Center, Lobby Level, Hall 2) - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1181;
AQST-109 is the first and only sublingual film using a novel prodrug of epinephrine (DESF) being developed for the same target indication as epinephrine injection in the emergency treatment of Type 1 allergic reactions...These results suggest that sublingual DESF provides comparable levels of epinephrine to that of IM epinephrine and achieved an epinephrine plasma Tmax in a significantly shorter time frame. Preliminary work suggests that sublingual DESF is a safe, alternative treatment that would address major unmet needs in patients at risk of anaphylaxis.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Journal: Motor response with apomorphine sublingual film and levodopa in patients with OFF episodes. (Pubmed Central) - Dec 24, 2022
Following an optimized SL-APO dose, mean improvements in MDS-UPDRS-III scores were -13.9 and -22.9, and FULL ON was achieved by 34.7 and 81.0% of patients. Concomitant administration of SL-APO with carbidopa/levodopa may be useful for delayed ON.

|||||||||| Teglutik (riluzole oral suspension) / Italfarmaco, Exservan (riluzole oral soluble film) / Aquestive, Zambon, Mitsubishi Tanabe, Radicava (edaravone) / Mitsubishi Tanabe
Review, Journal: Biological aspects of nitrogen heterocycles for amyotrophic lateral sclerosis. (Pubmed Central) - Dec 9, 2022
• Neurodegenerative diseases and their drawbacks are discussed in detail. • Recent survey of nitrogen heterocycles in treating ALS disease are highlighted.

||||||||||  Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Trial completion, Enrollment change:  Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease (clinicaltrials.gov) -  Nov 14, 2022
P3, N=427, Completed,  Sponsor: Sunovion
• Recent survey of nitrogen heterocycles in treating ALS disease are highlighted. Active, not recruiting --> Completed | N=226 --> 427

|||||||||| epinephrine (AQST-109) / Aquestive, epinephrine / Generic mfg., epinephrine (AQST-108) / Aquestive
$AQST Aquestive Therapeutics Receives Positive FDA Written Response for AQST-109 Epinephrine Sublingual Film https://t.co/i1BLBBRolO (Twitter) - Oct 11, 2022

|||||||||| riluzole / Generic mfg.
PK/PD data, Journal: Pharmacokinetics, Bioavailability, and Swallowing Safety With Riluzole Oral Film. (Pubmed Central) - Sep 29, 2022
No evidence of deterioration of swallowing function was observed post-dose. The ROF was bioequivalent to riluzole tablets, was well tolerated, and had no detrimental effect on swallowing.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Apomorphine sublingual film patient-reported motor status response at home throughout the day (Poster Station: 12) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_1015;
SL-APO self-administration led to a Full ON response in most patients regardless of the time of day and separation in-between dosing. Efficacy of doses following the first daily dose does not seem to be impacted by intake intervals of at least 2 hours.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Efficacy of Apomorphine Sublingual Film Versus Subcutaneous Apomorphine for the Treatment of OFF Episodes in Parkinson’s Disease (Poster Station: 22) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_767;
In this open-label, randomized, crossover study, efficacy of SL-APO and SC-APO for the treatment of OFF episodes in patients with PD was similar at all time points through 120 min postdose. Patients reported an overall preference for SL-APO over SC-APO at study endpoint.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Apomorphine Sublingual Film Versus Subcutaneous Apomorphine in the Treatment of OFF Episodes in Parkinson’s Disease: Results From an Assessment of Patient Satisfaction (Poster Station: 20) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_755;
In this open-label, randomized, crossover study, patients reported greater global satisfaction and convenience with SL-APO vs SC-APO. These findings suggest that SL-APO may provide an acceptable therapeutic alternative to SC-APO for the treatment of OFF episodes.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Safety and Tolerability of Apomorphine Sublingual Film and Subcutaneous Apomorphine for the Treatment of OFF Episodes in Parkinson’s Disease (Poster Station: 18) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_746;
In this open-label, randomized, crossover study, SL-APO and SC-APO were generally well tolerated in patients with PD and OFF episodes. The safety profiles of SL-APO and SC-APO were generally comparable and no new safety signals were identified.[table1]

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Apomorphine Sublingual Film Titrated at Home in Patients With Parkinson’s Disease and OFF Episodes: Results From an Open-Label, Randomized, Crossover Study (Poster Station: 13) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_718;
The safety profiles of SL-APO and SC-APO were generally comparable and no new safety signals were identified.[table1] In this open-label, randomized, crossover study, following an initial clinic visit, most patients were able to titrate SL-APO at home without supervision, with dose adjustment occurring in some cases.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Incremental Motor Improvement Observed with Increasing Doses (Poster Station: 13) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_716;
P3
Minimal change in MDS-UPDRS Part III scores between 30-45 mins postdose indicates that if a full ON response is not achieved by 30 mins, the patient may require a higher dose. Dose optimization may offer greater clinical benefit and should be attempted as tolerated.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Journal: A Randomized Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson's Disease. (Pubmed Central) - Sep 10, 2022
P2
Lower limits of 90% CIs for ΔΔQTcF of moxifloxacin exceeded the 5-millisecond regulatory threshold at all timepoints up to 3 hours, confirming assay sensitivity. SL-APO had no clinically meaningful effects on QTcB, PR/QRS intervals, heart rate, or electrocardiogram-derived morphology (EudraCT identifier: 2016-001762-29; ClinicalTrials.gov identifier: NCT03187301).

||||||||||  Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
New P4 trial:  Sublingual Apomorphine in Refractory Restless Legs Syndrome (clinicaltrials.gov) -  Sep 6, 2022
P4, N=16, Not yet recruiting,  Sponsor: William Ondo, MD

|||||||||| Libervant (diazepam buccal film) / Aquestive
FDA event: $AQST Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film https://t.co/Q6ptH9UwZx (Twitter) - Aug 31, 2022

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL, Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: Should "on-demand" treatments for Parkinson's disease OFF episodes be used earlier? (Pubmed Central) - Aug 30, 2022
Three "on-demand" treatments are currently available in the US as follows: subcutaneous apomorphine, levodopa inhalation powder, and sublingual apomorphine...Novel "on-demand" treatments bypass the gut and can improve OFF symptoms more rapidly and reliably than oral levodopa. With the emergence of novel "on-demand" treatments, we conclude that a shift in treatment paradigm to the earlier, complementary use of these medications be considered.

|||||||||| Clinical: The FDA has fast-tracked 3 potential needle-free epinephrine alternatives. AL delves into the data on Aquestive's epi film, @ars_pharma's Neffy nasal spray and the 2-shot Bryn Pharma spray. + allergists on: what they want to see on efficacy. @AAAAI_org @ACAAI @AllergyKidsDoc (Twitter) - Jun 29, 2022

|||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Use of On-Demand Treatments for OFF Episodes in Parkinson's Disease: Guidance from a RAND/UCLA Modified Delphi Consensus Panel () - Jun 24, 2022 - Abstract #MDSPAS2022MDS_PAS_112;
The greater the functional impact of OFF episodes, the more likely panelists agreed that on-demand treatment is appropriate to prescribe. On-demand treatment was also considered appropriate in patients whose OFF episodes do not interfere with daily activities but impact their lives in other ways (e.g., job performance, fear of leaving home).

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Antiemetics May Not Be Necessary for the Titration of Apomorphine Sublingual Film for the Treatment of "OFF" Episodes in Parkinson's Disease () - Jun 24, 2022 - Abstract #MDSPAS2022MDS_PAS_76;
P3
On-demand treatment was also considered appropriate in patients whose OFF episodes do not interfere with daily activities but impact their lives in other ways (e.g., job performance, fear of leaving home). This interim analysis of an ongoing long-term study examining the need for an antiemetic during titration with apomorphine sublingual film administration suggests that the majority of patients with PD and "OFF" episodes can be titrated to an efficacious and tolerable dose without the need for antiemetics.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Updated Population Pharmacokinetics Model of Apomorphine, Administered as a Sublingual Film or Subcutaneous Injection, in Healthy Subjects and Patients With Parkinson's Disease () - Jun 24, 2022 - Abstract #MDSPAS2022MDS_PAS_62;
Objective: To characterize apomorphine and apomorphine sulfate PK in healthy subjects and patients (pts) with Parkinson's disease (PD) after administration of apomorphine sublingual film (APL) and subcutaneous (SC) apomorphine, via a population-based approach... An updated population PK model described comparable and differentiated PK characteristics of apomorphine/apomorphine sulfate following administration of APL and SC apomorphine and continues to support its administration in pts with PD and "OFF" episodes, regardless of demographic and clinical characteristics.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Comparison of Pharmacokinetics of Apomorphine, Administered as a Sublingual Film or Subcutaneous Injection, Between Patients With Parkinson's Disease in Europe and North America () - Jun 24, 2022 - Abstract #MDSPAS2022MDS_PAS_61;
Apomorphine exposure was less than dose proportional with APL and slightly greater than dose proportional with SC-APO. Relative bioavailability of APL to SC-APO was <25%.

||||||||||  Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Trial completion date, Trial primary completion date:  Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease (clinicaltrials.gov) -  Jun 9, 2022
P3, N=226, Active, not recruiting,  Sponsor: Sunovion
Relative bioavailability of APL to SC-APO was <25%. Trial completion date: Jul 2022 --> Nov 2022 | Trial primary completion date: Jul 2022 --> Nov 2022

||||||||||  Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL
Enrollment closed:  Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease (clinicaltrials.gov) -  Apr 8, 2022
P3, N=226, Active, not recruiting,  Sponsor: Sunovion
Trial completion date: Jul 2022 --> Nov 2022 | Trial primary completion date: Jul 2022 --> Nov 2022 Recruiting --> Active, not recruiting

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL, Inbrija (levodopa inhalation powder) / Acorda
Journal: Indirect comparison of apomorphine sublingual film and levodopa inhalation powder for Parkinson's disease 'OFF' episodes. (Pubmed Central) - Mar 23, 2022
Total daily 'OFF' time reductions were significantly larger for APL versus CVT-301 (-1.31 h; p = 0.013). Results suggest APL treatment may lead to improved efficacy versus CVT-301.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Journal, HEOR: Cost-Effectiveness of Apomorphine Sublingual Film as an "On-Demand" Treatment for "OFF" Episodes in Patients with Parkinson's Disease. (Pubmed Central) - Feb 19, 2022
For CVT-301, cost-effectiveness of APL was driven by lower "on-demand" treatment costs and substantially higher efficacy. From a US payer perspective, APL represents a cost-effective option compared with SC-APO and CVT-301 for treatment of "OFF" episodes in patients with PD.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Clinical, PK/PD data, Journal: Population Pharmacokinetic Analysis of Apomorphine Sublingual Film and Subcutaneous Apomorphine in Healthy Subjects and Patients With Parkinson's Disease. (Pubmed Central) - Feb 15, 2022
Similar apomorphine exposure was predicted in patients with mild renal impairment versus normal renal function. PK properties of apomorphine sublingual film support its administration for a wide range of patients, regardless of demographic and clinical characteristics, with PD and "OFF" episodes.

|||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL
Journal: Dose optimization of apomorphine sublingual film for treating "OFF" episodes in Parkinson's disease. (Pubmed Central) - Feb 12, 2022
PK properties of apomorphine sublingual film support its administration for a wide range of patients, regardless of demographic and clinical characteristics, with PD and "OFF" episodes. Higher doses of apomorphine sublingual film than those initially perceived to provide an "ON" response can be tolerated and provide additional improvement in motor function in many patients.



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