Industry Briefs

FDA Rules Favorably on Efficacy of Travivo for Treating MDD

On March 17, Fabre-Kramer Pharmaceuticals announced that the the Food and Drug Administration (FDA) Office of New Drugs has concluded that there is evidence to support the effectiveness of the antidepressant Travivo (gepirone extended-release) for the treatment of major depressive disorder.

The decision overturns the FDA’s previous position on the medication, meaning Fabre-Kramer can now resubmit its New Drug Application for Travivo; once resubmitted, the FDA will have six months to review the amended application and reach a decision.

Travivo operates on a unique mechanism that selectively targets the 5HT1a serotonin receptor and has been shown to reduce symptoms of depression without causing sexual dysfunction and with fewer side effects than other antidepressants on the market.

FDA Issues New Safety Warnings for Opioids

The FDA released a statement last week warning of safety issues with opioid pain medications:

• Opioids can interact with antidepressants and migraine medicines to cause a serious reaction called serotonin syndrome, in which high levels of serotonin build up in the brain and become toxic.

• Opioid use may lead to a rare but serious condition in which the adrenal glands do not produce enough amounts of the stress hormone cortisol.

• Long-term opioid use may be associated with decreased sex hormone levels, leading to symptoms such as reduced interest in sex, impotence, or infertility.

The FDA will require all manufacturers to update information contained in the Drug Interactions and Adverse Reactions sections of opioid medication labels to include information about serotonin syndrome, adrenal insufficiency, and decreased sex hormone levels. ■