Authorities have approved a new weight-loss drug, Contrave, developed by La Jolla firm Orexigen Therapeutics, Inc (NASDAQ-OREX).

The Food and Drug Administration announced that the agency had given the go-ahead to Contrave, the name for naltrexone hydrochloride and bupropion hydrochloride extended-release tablets, as a treatment for those who are register body mass indexes of 27 or more.

Forbes has a breakdown of the history of the drug, also known as NB32. The FDA initially rejected Orexigen’s proposal for it three years ago.

For the drug to be recommended, those who are overweight must also suffer from at least one weight-related condition. The options include high blood pressure, type 2 diabetes or high cholesterol.

Contrave weds two FDA-approved drugs, naltrexone and bupropion, in an extended-release dose. Naltrexone is approved to treat alcohol and drug dependence, while bruspropion is sanctioned to treat depression, seasonal affective disorder and smoking cessation.

Contrave, by Orexigen Thearapeutics in La Jolla. Photo credit: blog.yourbestfatburner.com

The FDA said Contrave was tested in multiple clinical trials on approximately 4,500 obese and overweight patients with and without major weight-related conditions over the course of a year. Those in the trials combined the treatment with fewer calories in their diets and additional exercise.

In one of the trials, patients without diabetes had an average weight loss of 4.1 percent when treated with Contrave vs. those using placeboes; 42 percent of patients who used Contrave lost at least 5 percent of their body weight.

Results from another trial with patients suffering from type 2 diabetes showed that they had an average weight loss of 2 percent with Contrave as compared to placeboes. In this trial, 36 percent of patients who used Contrave lost at least 5 percent of their body weight.

The FDA recommends that patients prescribed Contrave should be evaluated after three months. If a patient has not lost at least 5 percent of their body weight at that point, regulators say doctors should stop offering it as a treatment.

The FDA issued a number of warnings about the new drug. Since it contains bupropion, Contrave will feature a warning about an increased risk of suicidal thoughts. The warning also notes that serious “neuropsychiatric events” have been reported in patients using bupropion to quit smoking.

There is a risk of seizures, higher blood pressure and heart rates as well.

The most common adverse reactions to Contrave, the FDA said, include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

There will be more study of the drug too. The tests the FDA is calling for include:

  • a “cardiovascular outcomes trial” to test risks associated with Contrave
  • two studies in pediatric patients, one ages 12 to 17, and the other, from 7 to 11 years old
  • a clinical trial to test the how Contrave and other drugs interact

Contrave will be distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen.

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