suvecaltamide (JZP385) / Jazz 
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  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Contribution to Efficacy by Active Metabolites of Suvecaltamide in a Preclinical Rat Model of Essential Tremor (Poster Hall (Exhibit Hall A)) -  Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1678;    
    P2
    These results illustrate contributions to efficacy by active suvecaltamide metabolites in rats, which must be considered clinically given they are predicted to translate to human efficacy. These data support the continued clinical development of suvecaltamide for adults with moderate-to-severe ET (NCT05122650) or residual Parkinson's disease tremor (NCT05642442).
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Suvecaltamide Metabolites Are CaV3 Modulators and Contribute to Pharmacological Effect (Poster Hall (Exhibit Hall A)) -  Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1677;    
    P2
    Modelling TAM shows that, at clinically relevant concentrations, suvecaltamide and its metabolites may selectively inhibit channels enriched under hyperexcitable conditions (eg, pathological neuronal firing) while sparing channels involved in normal signalling, which may contribute to a more optimal clinical profile. Two ongoing phase 2 studies are evaluating suvecaltamide in adults with moderate-to-severe ET (NCT05122650) or residual Parkinson's disease tremor (NCT05642442).
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Once-Daily Suvecaltamide Pharmacokinetics, Safety, & Tolerability (Poster Hall (Exhibit Hall A)) -  Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_827;    
    P2
    Two ongoing phase 2 studies are evaluating suvecaltamide in adults with moderate-to-severe ET (NCT05122650) or residual Parkinson's disease tremor (NCT05642442). Results from this Phase 1 study expand our understanding of suvecaltamide PK, safety, and tolerability, supporting further clinical development of the QD formulation of suvecaltamide.
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Design of a Phase 2 Study of Suvecaltamide in Moderate-to-severe Parkinson's Disease Tremor (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_3194;    
    P2
    Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2024 The phase 2 proof-of-concept study for the efficacy of suvecaltamide to treat the functional impact of PDT represents the first large clinical study informing the use of TETRAS to assess tremor in this population.
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Design of a Phase 2 Study of Suvecaltamide in Moderate to Severe Parkinson () -  Aug 30, 2023 - Abstract #MDSCongress2023MDS_Congress_1544;    
    P2
    Phase classification: P2b --> P2 | Trial completion date: Dec 2023 --> May 2024 | Trial primary completion date: Nov 2023 --> May 2024 The phase 2 study will serve as proof-of-concept for the efficacy of suvecaltamide to treat the functional impact of tremor in Parkinson
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Anti-tremor efficacy of suvecaltamide in a rat model of essential tremor (SDCC Halls B-H) -  Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_6753;    
    P2, P2b
    Oral suvecaltamide effectively reduced tremor in rats pre- or post-harmaline, and in a manner superior to propranolol, supporting the continued development of suvecaltamide for the treatment of ET. An ongoing phase 2b trial (NCT05122650) will further evaluate the safety and efficacy of suvecaltamide for adults with moderate to severe ET.
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Preclinical Characterization of Suvecaltamide for Essential Tremor (Poster Station: 26) -  Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_954;    
    Suvecaltamide inhibited all CaV3 subtypes with low nM potency in a state-dependent manner and effectively reduced tremor in rats when administered orally pre- or post-harmaline, supporting the continued development of suvecaltamide for the treatment of ET. An ongoing phase 2b trial will further evaluate the safety and efficacy of suvecaltamide for adults with moderate to severe ET [2].
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Enrollment change:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  Sep 8, 2022   
    P2a,  N=7, Completed, 
    An ongoing phase 2b trial will further evaluate the safety and efficacy of suvecaltamide for adults with moderate to severe ET [2]. N=15 --> 7
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Short and practical asymmetric synthesizes of Merck drug candidates: MK-2305 and MK-8998 (W176b (McCormick Place Convention Center)) -  Aug 9, 2022 - Abstract #ACSFall2022ACS_Fall_6011;    
    N=15 --> 7 Herein, we report short, protecting group free, high yielding and scalable asymmetric synthesizes of MK-2305 (a highly potent GPR40 agonist) and MK-8998 (a T Type Calcium Channel Antagonist).
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    P2/3 data, Clinical Trial,Phase III, Journal:  Epilepsy: Expert opinion on emerging drugs in phase 2/3 clinical trials. (Pubmed Central) -  Apr 6, 2022   
    Novel mechanisms of action involve cholesterol degradation, mitochondrial pathways, anti-inflammation and neuro-regeneration. Earlier identification of genetic conditions through genetic testing will allow for earlier use of disease specific and disease-modifying therapies.
  • ||||||||||  amantadine / Generic mfg.
    Review, Journal:  Non-Dopaminergic Treatments for Motor Control in Parkinson's Disease: An Update. (Pubmed Central) -  Oct 22, 2021   
    Long-acting formulations of amantadine are approved for treating dyskinesia...For example, CX-8998 (a calcium channel modulator) is being evaluated for PD tremor and rivastigmine may improve gait dysfunction in PD. Drug repurposing continues to be a key strategy for non-dopaminergic targets in PD, but the field needs to increase discovery and availability of such drugs.
  • ||||||||||  JZP-385 / Jazz
    Clinical, P2 data, Journal:  A Phase 2 Proof-of-Concept, Randomized, Placebo-Controlled Trial of CX-8998 in Essential Tremor. (Pubmed Central) -  Sep 2, 2021   
    The study design seeks to overcome limitations of prior research and build upon the proof-of-concept study by moving beyond measures of tremor amplitude to focus on more clinically relevant assessments of functional impairment. The primary efficacy end point was not met; however, CX-8998 improved some assessments of essential tremor, supporting further clinical investigation.
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Enrollment change, Trial withdrawal:  A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease (clinicaltrials.gov) -  May 28, 2021   
    P2,  N=0, Withdrawn, 
    The primary efficacy end point was not met; however, CX-8998 improved some assessments of essential tremor, supporting further clinical investigation. N=60 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion date, Trial primary completion date:  A Phase 2 RCT Study of CX-8998 for Essential Tremor (clinicaltrials.gov) -  Apr 24, 2020   
    P2,  N=95, Completed, 
    For participants with more severe tremor at baseline, the treatment effect with CX­8998 may be larger in absolute value relative to those with less severe baseline tremor. Trial completion date: Sep 2018 --> May 2019 | Trial primary completion date: Sep 2018 --> May 2019
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  Apr 3, 2020   
    P2a,  N=15, Completed, 
    Trial completion date: Sep 2018 --> May 2019 | Trial primary completion date: Sep 2018 --> May 2019 Active, not recruiting --> Completed
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Enrollment closed:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  May 10, 2019   
    P2a,  N=15, Active, not recruiting, 
    Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03101241. Suspended --> Active, not recruiting
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion date, Trial initiation date, Trial primary completion date:  A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease (clinicaltrials.gov) -  Apr 8, 2019   
    P2,  N=60, Not yet recruiting, 
    Suspended --> Active, not recruiting Trial completion date: Dec 2019 --> Dec 2020 | Initiation date: Dec 2018 --> Dec 2019 | Trial primary completion date: Sep 2019 --> Sep 2020
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion date, Trial suspension, Trial primary completion date:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  Mar 18, 2019   
    P2a,  N=15, Suspended, 
    Trial completion date: Dec 2019 --> Dec 2020 | Initiation date: Dec 2018 --> Dec 2019 | Trial primary completion date: Sep 2019 --> Sep 2020 Trial completion date: Mar 2019 --> Dec 2019 | Recruiting --> Suspended | Trial primary completion date: Jan 2019 --> Dec 2019
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion date:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  Nov 21, 2018   
    P2a,  N=15, Recruiting, 
    Trial completion date: Mar 2019 --> Dec 2019 | Recruiting --> Suspended | Trial primary completion date: Jan 2019 --> Dec 2019 Trial completion date: Nov 2018 --> Mar 2019
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion:  A Phase 2 RCT Study of CX-8998 for Essential Tremor (clinicaltrials.gov) -  Oct 9, 2018   
    P2,  N=95, Completed, 
    Trial completion date: Nov 2018 --> Mar 2019 Recruiting --> Completed
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Enrollment change:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  Jul 30, 2018   
    P2a,  N=15, Recruiting, 
    Recruiting --> Completed N=30 --> 15
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial completion date, Trial initiation date, Trial primary completion date:  A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease (clinicaltrials.gov) -  Jul 19, 2018   
    P2,  N=60, Not yet recruiting, 
    N=30 --> 15 Trial completion date: Aug 2019 --> Dec 2019 | Initiation date: Apr 2018 --> Dec 2018 | Trial primary completion date: Jun 2019 --> Sep 2019
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    New P2a trial:  CX-8998 for Absence Seizures (clinicaltrials.gov) -  Jan 23, 2018   
    P2a,  N=30, Recruiting, 
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Trial primary completion date:  A Phase 2 RCT Study of CX-8998 for Essential Tremor (clinicaltrials.gov) -  Dec 7, 2017   
    P2,  N=92, Recruiting, 
    Trial completion date: Aug 2019 --> Dec 2019 | Initiation date: Apr 2018 --> Dec 2018 | Trial primary completion date: Jun 2019 --> Sep 2019 Trial primary completion date: Jun 2018 --> Sep 2018
  • ||||||||||  suvecaltamide (JZP385) / Jazz
    Enrollment open:  A Phase 2 RCT Study of CX-8998 for Essential Tremor (clinicaltrials.gov) -  Jun 27, 2017   
    P2,  N=92, Recruiting, 
    Trial primary completion date: Jun 2018 --> Sep 2018 Not yet recruiting --> Recruiting