July 9, 2010

New Pills Hope To Fight Obesity Without Past Problems

The first of three new fat-fighting drugs will face public examination by US regulatory advisers next week, as pharmaceutical companies target the growing number of overweight Americans despite a less than glamorous past for weight-loss pills.

Three drug makers -- Vivus Inc, Arena Pharmaceuticals Inc and Orexigen Therapeutics Inc -- are trying to succeed where other efforts have failed after several weight-loss drugs were linked to serious and dangerous side effects.

The Food and Drug Administration will seek input from outside sources July 15 on Vivus' pill, Qnexa, for use with diet and exercise. If the drug is approved, it will be the first new prescription weight-loss drug in ten years in the USA.

Obesity drugs have a troubled history, with many never gaining approval, or being pulled from the market after sales begun, or were labeled with severe health warnings.

"The history of weight-loss drugs is such that it's a no-brainer that the FDA is going to take each and every one to an advisory panel,"analyst Ira Loss, who follows the agency for Washington Analysis Corp., told Reuters.

An advisory panel is one of the last steps in a drug's route to getting approval. The FDA makes the final decision, but it usually follows the advice of its advisors.

Qnexa, which combines the appetite suppressant phentermine with the anti-seizure drug topiramate, aims to treat obese and overweight people with related health problems. The maker, Vivus, is trying to improve on the tarnished "fen-phen" diet drug that combined fenfluramine with phentermine. While the former was withdrawn due to safety concerns, phentermine is considered safe at low doses. Topiramate is an anticonvulsant that can curb appetite.

Other companies are also seeking FDA approval for their weight-loss drugs.

Arena hopes to get approval for Lorcaserin, a new type of drug that targets the part of the brain that controls metabolism and appetite. A public FDA meeting has been tentatively scheduled for September 16, according to the company.

Orexigen said the FDA will hold a public review for its candidate, Contrave, in December. Contrave combines naltrexone, used to fight alcohol and drug addiction, and the antidepressant bupropion. It aims to target cravings, curb appetite and boost metabolism.

All three drugs, if approved, would be a huge boost for their relatively small makers.

Analysts expect Qnexa to bring in nearly $700 million in sales by 2014, if it gets approval.

Roughly 68 percent of US adults -- nearly 211 million -- are overweight or obese, according to the US Centers for Disease Control and Prevention. While weight loss can be managed through diet and exercise, some medicines can also help.

Although the past has been very troubling for many weight-loss prescription drug makers, others are hoping to offer much better results.

Side effects of the three potential new drugs include headaches, infection, nausea, constipation and dry mouth.

Orexigen Chief Executive Officer Michael Narachi said he was keeping an eye on the July 15 Vivus meeting to get a sense of the FDA's latest stance on obesity products. "The best-case scenario is all of these drugs get approved for some appropriate population," he said.

Arena is placing its hopes on the fact that its drug is the only one of the three that uses an entirely new chemical. "There's clearly a need for better agents," said Dominic Behan, Arena's chief scientific officer and co-founder.

Vivus is expecting the FDA to make its final decision on Qnexa by October 28.

All three companies must prove that their therapies will not repeat the past.


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