Alkermes has a tentative fall date with a virtual FDA review committee that will focus on potential drug-drug interactions (DDIs) for its experimental schizophrenia and bipolar med.
The FDA has marked Oct. 9 as a “tentative” date for its new virtual AdComm format for Alkermes’ ALKS 3831 (olanzapine/samidorphan) and has told the biopharma it wants to focus on DDIs.
“The company has learned that the panel will also discuss certain potential clinical risks related to the interaction of ALKS 3831, which includes samidorphan, an opioid receptor antagonist, and opioids in the intended patient populations,” Alkermes said in a statement.
Its drug is composed of samidorphan, a new molecular entity, combined with with Eli Lilly's atypical antipsychotic Zyprexa (olanzapine).
Previously, the company thought the FDA advisory panel’s focus would be on the drug increasing weight in patients, a known problem with olanzapine.
But it hopes to have a handle on this, and in 2018 published data out of its ENLIGHTEN-2 study, which compared ALKS-3831 to olanzapine in 561 patients with stable schizophrenia.
After six months of treatment, patients taking olanzapine had a 57% higher weight gain from baseline compared to patients on ALKS-3831. And olanzapine patients were more likely to put on greater amounts of weight—they had twice the risk of gaining 10% or more of their baseline body weight compared to patients on ALKS-3831. The DDI discussion appears to have taken Alkermes a little by surprise.
“We look forward to engaging with members of the joint advisory committee panel in a robust discussion of the clinical evidence for ALKS 3831,” said Craig Hopkinson, M.D., chief medical officer and executive vice president of research at Alkermes.
“For adults living with schizophrenia or bipolar I disorder, populations already prone to shortened life expectancy and cardiovascular comorbidities, the significant weight gain often associated with olanzapine can represent a major clinical liability.
“Patients and healthcare providers may benefit from additional treatment options that help manage disease symptoms while mitigating weight gain. We are committed to bringing this potential new medicine to adults living with schizophrenia or bipolar I disorder.”
The company will hope to have better luck than with ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan that was turned down by the FDA last year for major depressive disorder. Alkermes said the FDA wants additional clinical data, namely to prove its effectiveness.