After Prolonged Review, FDA Approves Orexigen’s Weight-Loss Drug

Xconomy San Diego — 

The FDA today approved a new weight-loss drug for people who are obese or overweight with at least one weight-related health condition, easing a burden that San Diego’s Orexigen Therapeutics (NASDAQ: OREX) has been carrying for a long time.

Orexigen experienced several setbacks while advancing the drug, an extended release formulation of two previously approved drugs, naltrexone and bupropion, which the company plans to market with Japan’s Takeda Pharmaceutical as Contrave. Naltrexone is an opioid blocker approved in 1984 for treating drug addiction, but now used primarily for alcohol dependence. Bupropion is a widely used antidepressant and smoking cessation drug.

It is Orexigen’s first drug approval, and the third obesity drug approved by U.S. drug regulators since 2012.

The company initially submitted its new drug application to the FDA in early 2010, and an FDA advisory panel gave its OK in a 13-7 vote at the end of that year. But the biopharmaceutical company said it was shelving the program in mid-2011, after the FDA  told Orexigen it would have to conduct a long-term clinical study of more than 60,000 patients to determine if Contrave posed a risk for heart attacks and other adverse cardiovascular events.

Work resumed, however, after Orexigen later proposed a cardiovascular study that would draw on existing data from almost 10,000 patients who had participated in a late-stage trial of Contrave. The company revised the application for Contrave and finally submitted it at the end of 2013. Trading in Orexigen shares began to climb as investors anticipated final regulatory approval in mid-June. Instead, there was more delay: the FDA extended its review to refine details of Orexigen’s post-marketing obligations for a continuing assessment of the drug’s potential cardiovascular risk.

In its statement today, the FDA says it has cleared Orexigen’s pill as another treatment for people who are obese or overweight and who have type 2 diabetes or a similar weight-related health condition. The agency says the drug is intended to reduce appetite and control cravings, and should be prescribed as part of a healthy lifestyle regimen that includes a reduced-calorie diet and exercise.

Contrave is the third weight-loss pill to hit the market in the last two years, and will compete against lorcaserin HCL (Belviq), co-marketed by San Diego-based Arena Pharmaceuticals (NASDAQ: ARNA) and Japan’s Eisai, and the combination of phentermine and topiramate that Mountain View, CA-based Vivus sells as Qsymia.

Arena’s Craig Audet said he welcomes the competition. “There’s so much room for growth here that we don’t have to go after each other in terms of market share,” said Audet, who is Arena’s senior vice president of operations and head of global regulatory affairs.

Almost 79 million American adults are obese, a condition that carried $147 billion in medical costs in 2008, according to the Centers for Disease Control and Prevention. Yet only 2 percent of the people who meet the treatment criteria as obese or overweight are being prescribed weight-loss drugs, Audet said.

With more Orexigen sales reps promoting the benefits of Contrave, Audet said he anticipates greater public awareness as a growing number of voices calling for improved weight-loss care. He also expects physicians will become more attuned to the particular strengths and weaknesses of each drug.

The FDA approved Contrave for obese adults with a body mass index (BMI) of 30 or greater or overweight adults with a BMI of 27 or greater who have at least one weight-related health condition.

Orexigen said late today it has scheduled a conference call and webcast at 8:30 am ET Thursday for top executives to talk with investors and analysts about what happens next.