Pharma

Alkermes’ schizophrenia drug shows lower weight gain than comparator

The company plans to file a New Drug Application next year. An analyst wrote that it's unclear if the drug will require review by an advisory committee.

By Alaric DeArment on November 29, 2018

Less than four weeks after it received a negative review from a Food and Drug Administration expert panel for its antidepressant, drugmaker Alkermes has successful results from a Phase III trial in schizophrenia.

The Dublin-based drugmaker said Wednesday that its second trial of the drug ALKS 3831 (olanzapine/samidorphan), ENLIGHTEN-2, met both of its co-primary weight-related endpoints. Olanzapine alone – which was also the comparator in the 561-patient trial – is associated with significant weight gain in patients, and the combination is designed to mitigate that effect. The other trial, ENLIGHTEN-1, evaluated the drug’s antipsychotic safety, efficacy and tolerability for ALKS 3831 compared with placebo in 403 patients, with positive topline data released in June 2017. The company plans to file for FDA approval of the drug in the middle of next year.

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The study showed that ALKS 3831 achieved both a lower mean percent weight gain from base line at six months compared to olanzapine alone and a lower proportion of patients who gained 10 percent or more of their baseline body weight at six months compared to the control arm. In addition, on the key secondary endpoint of the proportion of patients who gained 7 percent or more of their baseline body weight at six months, the combination drug was also successful. On all three measures, p-values indicated statistical significance.

Serious adverse events occurred in 3.6 percent of patients in the ALKS 3831 arm, compared with 2.5 percent of those in the olanzapine arm. Side effects included weight gain, somnolence and dry mouth for the study drug and weight gain, somnolence and increased appetite for olanzapine.

The results mean the drug is on track for its regulatory filing next year, an analyst at B. Riley FBR wrote, giving Alkermes’ stock a “buy” rating. It is unclear at this point if an FDA advisory committee meeting would be necessary as part of the agency’s review, the analyst wrote.

The results stand in contrast with the negative outcome earlier this month at a meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee for the company’s antidepressant, ALKS 5461. On Nov. 2, the PDAC voted 21-2 that the drug’s risk-benefit profile was insufficient to support its approval by the FDA. While the agency is not bound by advisory committee votes, it usually follows them, meaning it is doubtful ALKS 5461 will win approval. The vote followed briefing documents released earlier that week that had already cast doubt on the outcome of the vote, raising concerns about safety and efficacy and criticizing the use of an abbreviated scoring system for measuring efficacy.

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