Updated: Oct 18, 2020
Alkermes plc. announced positive voting outcomes from the joint meeting of the Drug Safety and Risk Management and the Psychopharmacologic Drugs advisory Committees, appointed by the FDA. The committees voted 16-1 in favor of the efficacy of ALKS 3831 (olanzapine/samidorphan) as a treatment for both bipolar I disorder and schizophrenia. The committee members also voted 13-3 in support of the investigational drug’s safety profile. One abstention was recorded in that vote.
"The favorable outcome of today's joint advisory committee meeting represents an important milestone for the patients, clinicians, and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder. The personal testimonies shared during today's open public hearing reinforced the need for treatment approaches that consider patients' overall mental and physical health," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "The ALKS 3831 development program is part of our ongoing commitment to developing new therapeutic options for adults living with serious mental illness. Today's outcome marks an important step for this program, and we look forward to working with the FDA as it completes its review of the ALKS 3831 New Drug Application."
Prior to the advisory committee meeting, there were a few questions concerning likely hurdles facing ALKS 3831. In particular, FDA staff members raised concerns over the possibility of abuse due to the fact that the drug’s composition contains an opioid antagonist. The drug consists of samidorphan, an opioid antagonist that is a new molecular entity, and Eli Lily's Zyprexa, a well-established schizophrenia drug. Samidorphan was listed in the drug's composition as a means of curtailing weight gain and other side effects that have been majorly established to the Eli Lilly medication. Weight gain is particularly a concern for patients taking second-generation antipsychotics such as Zyprexa due to its relationship to metabolic syndrome.
In its briefing documents for the advisory committee, the FDA emphasized on likely safety risks from the inclusion of samidorphan. Specifically, the FDA emphasized withdrawal concerns for individuals who have an opioid dependency and fears over a reduced painkilling effect in patients already on opioids. There are also fears for likely attempting to take more opioids than normal to overcome these issues, the FDA disclosed.
Alkermes said it believed proper labeling on the medication could ease a number of those of concerns, and the advisory committee seemed to concur. Alkermes’ proposed labeling contraindicates the use of ALKS 3831 in patients who are opioid-dependent or chronically on opioids, and the firm has proposed a detailed education plan. The plan includes dissemination of information to interested pharmacists and prescribers.
The advisory committee's recommendations are not binding yet. However, the FDA will most likely follow the ruling during approval sittings. The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is November 15.