Developer

Avanir Pharmaceuticals

1compound
3programs
3indications
Discontinuedlead asset

Phase distribution

  • Discontinued3

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

Catalysts · 0 upcoming · 4 reported

Recently reported

Recent activity

  • May 22, 2024Phase changeAVP-786 (deudextromethorphan-quinidine)·Agitation in Alzheimer's diseaseDiscontinuedOtsuka announced termination of AVP-786 development for agitation associated with dementia due to Alzheimer's disease after detailed analysis of the failed study 305. The ongoing Phase 3 studies 306 (NCT04408755) and 307 (NCT04464564) were terminated in June 2024 and the long-term extension 303 (NCT02446132) in September 2024, each with the ClinicalTrials.gov reason 'The AVP-786 program was discontinued'.source ↗
  • May 22, 2024Phase changeAVP-786 (deudextromethorphan-quinidine)·Treatment-resistant depressionDiscontinuedTerminal state anchored to Otsuka's molecule-wide termination of AVP-786 development (announced 2024-05-22 after the Alzheimer's-agitation Phase 3 failure) - the first and only citable sponsor statement ending all AVP-786 development. In practice the depression program was de facto abandoned after the 2016 study completion (no disclosure, no follow-on study in eight years), but no source dates that decision, so the citable upper bound is used rather than an invented earlier date.source ↗
  • Feb 13, 2024ReadoutAVP-786 (deudextromethorphan-quinidine)·Agitation in Alzheimer's diseasemissedStudy 305 topline (2024-02-13): no statistically significant difference vs placebo on the CMAI primary; falls 8.6%/9.1% on AVP-786 vs 2.8% on placebo. The result that triggered termination of the AVP-786 program on 2024-05-22.source ↗
  • May 23, 2023Phase changeAVP-786 (deudextromethorphan-quinidine)·SchizophreniaDiscontinuedStudy 207 terminated at the pre-planned interim analysis: 'Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility' (ClinicalTrials.gov whyStopped; 136 of a planned ~582 enrolled). The date is the trial's actual completion date on termination - Otsuka's internal decision date was never disclosed and no press release exists. This ended schizophrenia development; the molecule itself was terminated across all indications in May 2024.source ↗
  • Sep 16, 2020ReadoutAVP-786 (deudextromethorphan-quinidine)·SchizophreniamissedPhase 2 study 202 results posted to ClinicalTrials.gov: adjunctive AVP-786 missed the NSA-16 primary in residual schizophrenia (SPCD weighted z -1.79, p=0.073) - a trend, never announced by the company.source ↗
  • Sep 27, 2019ReadoutAVP-786 (deudextromethorphan-quinidine)·Agitation in Alzheimer's diseasemissedTRIAD-2 topline (2019-09-27): primary and key secondary endpoints not met - neither AVP-786 dose separated from placebo on CMAI change to week 12 (posted results p=0.789 and p=0.200).source ↗
  • Mar 25, 2019ReadoutAVP-786 (deudextromethorphan-quinidine)·Agitation in Alzheimer's diseasemixedTRIAD-1 topline (2019-03-25): mixed - the SPCD-combined CMAI primary was met on the higher AVP-786 dose (42.63 mg d6-DM/4.9 mg Q; posted-results p=0.008) but not the lower 28 mg dose (p=0.208).source ↗
  • Feb 15, 2019Phase changeAVP-786 (deudextromethorphan-quinidine)·SchizophreniaPhase 2/3Phase 2/3 study 207 (NCT03896945) started per ClinicalTrials.gov: multicenter, randomized, double-blind, placebo-controlled, parallel-arm study of adjunctive AVP-786 for negative symptoms of schizophrenia; primary endpoint change from baseline to week 15 in the PANSS Marder negative factors score.source ↗
  • Jul 21, 2017Phase changeAVP-786 (deudextromethorphan-quinidine)·SchizophreniaPhase 2Study 202 completed (145 enrolled). Posted results (first posted to ClinicalTrials.gov 2020-09-16) show the SPCD weighted primary analysis of NSA-16 change did not reach significance: weighted OLS z-statistic -1.79, p=0.073. No company announcement of these results was ever made.source ↗
  • Feb 1, 2016Phase changeAVP-786 (deudextromethorphan-quinidine)·Treatment-resistant depressionPhase 2Study 201 completed per ClinicalTrials.gov (February 2016, 206 enrolled). No topline was ever announced, no publication found, and no results were ever posted to the registry - the program went silent from this point.source ↗
  • Sep 1, 2015Phase changeAVP-786 (deudextromethorphan-quinidine)·SchizophreniaPhase 2Phase 2 study 202 (NCT02477670) started per ClinicalTrials.gov (start date September 2015): a multicenter, randomized, double-blind, placebo-controlled SPCD study of AVP-786 as adjunctive therapy for negative symptoms in patients with residual schizophrenia on stable atypical antipsychotic treatment; primary endpoint NSA-16 total score at weeks 6 and 12.source ↗
  • Jul 23, 2015Phase changeAVP-786 (deudextromethorphan-quinidine)·Agitation in Alzheimer's diseasePhase 3TRIAD-1 (NCT02442765, 15-AVP-786-301), the first Phase 3, started per ClinicalTrials.gov; TRIAD-2 (NCT02442778) followed 2015-11-11 and the long-term extension 303 (NCT02446132) 2015-11-13. FDA Fast Track for agitation in Alzheimer's dementia was granted in November 2015. The program went straight to Phase 3 on the strength of the parent AVP-923 (dextromethorphan/quinidine) Phase 2 agitation signal plus Phase 1 PK bridging of the deuterated form.source ↗

Competitive landscape

Other companies developing against Avanir Pharmaceuticals's targets or indications.