Acadia Pharmaceuticals’ (ACAD) pimavanserin received a positive opinion from a panel of outside experts to the U.S. FDA on Tuesday, a final step before the regulatory body decides on the drug’s approval in Parkinson’s Disease Psychosis this May.
Though FDA reviewers took issue with the drug’s potential safety issues (FDA determined that for every 2 patients who benefit from the drug 1 patient will experience a serious adverse event) and the risk that pimavanserin is used off label in other settings, the 14 panel members voted almost unanimously in favor of its approval.
- Question 1: Has the applicant provided substantial evidence of the effectiveness for pimavanserin for the treatment of psychosis associated with Parkinson’s disease?
- 12 -Yes 2- No
- Question 2: Has the applicant adequately characterized the safety profile of pimavanserin?
- 11-Yes 3-No
- Question 3: Do the benefits of pimavanserin for the treatment of psychosis associated with Parkinson’s disease outweigh the risk of treatment?
- 12- Yes 2-No
Panel members, however, suggested that the drug’s approved label include a boxed warning, already largely expected by the investing community.
Pimavanserin, or NUPLAZID (proposed trade name), was tested in three controlled and blinded phase 3 studies: -012, -014, and -020. Only the last was successful, with pimavanserin outperforming placebo on a modified form of the Scale for the Assessment of Positive Symptom (SAPS) that consisted of nine items from the hallucinations and delusions domains.
The FDA has set a PDUFA action date of May 1, 2016. Prior to Monday’s close (ACAD was halted Tuesday), options implied a move of $10-12 with the approval decision in a month’s time. ACAD closed Monday at $23.81.
