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Adial Pharma Sees Clear, Cost-Effective Path Toward FDA Approval For Alcohol Use Disorder Candidate

  • Adial Pharmaceuticals Inc ADIL shares are trading higher after an update on its regulatory strategy for AD04, the company’s lead compound for Alcohol Use Disorder (AUD).
  • The company said additional analysis of ONWARD data identified specific genotypes that outperformed others. The data exhibited AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients – the “heavy drinkers.” 
  • Adial believes there is a clear, cost-effective path toward FDA approval that it plans to pursue aggressively.
  • Also Read: Adial Pharma Touts Positive Preclinical Data From Chronic Pain Candidate.
  • Based on the information collected and analyses to date, Adial has submitted a Type C meeting request to the FDA and was granted a meeting, which will be held in Q2 of 2023. 
  • The Type C meeting is expected to provide Adial with confirmation of a clear clinical development plan. 
  • As previously anticipated, an additional Phase 3 trial may be required. Adial intends to engage a U.S. partner to assist with funding the required clinical trial and to advance commercialization efforts. 
  • Adial is progressing discussions with five European country-level regulatory authorities: France, Sweden, Finland, the U.K., and Germany.
  • Meeting dates with Sweden and Germany are scheduled for March and April of 2023, respectively, and the remaining countries’ schedules are pending confirmation. 
  • Price Action: ADIL shares are trading flat at $0.42 on the last check Tuesday.

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