Industry Briefs

Alkermes’ Compound Found to Reduce Symptoms of Major Depression

The combination drug composed of samidorphan and buprenorphine made by Alkermes’—ALKS 5461—shows promise as an adjunctive therapy to standard antidepressants for treatment-resistant depression.

In a randomized phase 3 study (FORWARD-5) with ALKS 5461, data were analyzed from 407 individuals with major depression who responded inadequately to either selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. The drug was found to be significantly superior to placebo as an adjunctive therapy at a once-daily dose of 2 mg for each drug in the combination. The superiority determination was made on the basis of the subjects’ scores on the six- and 10-item Montgomery-Asberg Depression Rating scales.

The most commonly reported side effects included nausea, dizziness, and fatigue.

Following announcement of the trial’s results, Alkermes said that it planned to meet with the Food and Drug Administration Division of Psychiatric Products to discuss the filing strategy for ALKS 5461, which has already been granted Fast Track designation.

Endo Begins Marketing on Generic Seroquel XR

Earlier this month Endo International Plc. announced that one of its operating companies, Par Pharmaceutical, began shipping generic versions of quetiapine fumarate extended-release (ER) tablets in four dosage strengths: 50 mg, 150 mg, 200 mg, and 300 mg. The drug is marketed by AstraZeneca as Seroquel XR.

Par will have 180 days of marketing exclusivity for Seroquel XR generics.

Seroquel XR is a once-daily tablet approved for many indications, including schizophrenia, major depression (as an adjunctive treatment to antidepressants), acute depressive episodes in bipolar disorder, and acute manic or mixed episodes in bipolar disorder. It is also approved as a long-term adjunctive treatment to lithium and divalproex for bipolar disorder. ■