After suffering a complete response letter a little over a month ago, Alkermes quickly sorted out the manufacturing shortfalls that blighted its experimental med—and now, the FDA has set a potential approval date this summer.
It’s been a roller coaster 18 months for Alkermes, which ended 2019 by axing staffers and cutting spending after its depression drug ALKS 5461 was rejected earlier in the year.
It looked as if it were a case of history repeating itself in November when, despite a broadly positive advisory committee vote, the FDA rejected its schizophrenia and bipolar I hopeful because of manufacturing problems at the company’s Wilmington, Ohio, facility.
Those problems were quickly rectified, the company said, and, with no clinical issues cited in its CRL, the FDA has accepted Alkermes’ refiling and offered up a decision date of June 1.
“The observations noted in the CRL were specific to certain development batches of ALKS 3831,” Alkermes said in a statement. “The company believes this issue has since been resolved and that sufficient data is available to address these observations.”
Its drug combines olanzapine, the active ingredient of Zyprexa, with samidorphan, an opioid antagonist designed to counter the weight gain and metabolic side effects of Eli Lilly’s antipsychotic.
It will now focus on its marketing plans, should the med gain that summer approval, though sales aren’t likely to be an easy task, either. During its AdComm in the fall, the panelists’ main question was how samidorphan might affect patients taking opioids like morphine or oxycodone.
In briefing documents published by the FDA, agency staff spotlighted multiple issues for these patients, including a reduced painkilling effect in patients, withdrawal symptoms in patients dependent on opioids and opioid overdose if patients try to overcome either of these problems by taking more opioids than normal.
Alkermes says it plans to tackle these issues in the drug’s labeling, which will echo those of approved drugs that contain opioid antagonists like naltrexone, the active ingredient of Vivitrol, Alkermes’ treatment for opioid and alcohol dependence. But in an 11-6 vote, the FDA’s panel disagreed on whether labeling would be enough.
In its statement today, Alkermes said it is planning “to work closely with the Agency [and] complete labeling discussions for the application.”
The company’s shares were up 3.5% premarket Tuesday morning.