FDA Votes No To Jazz Drug

On Aug. 20, 2010, a U.S. Food and Drug Administration (FDA) advisory panel voted 20-2 against approving the drug known as sodium oxybate (JZP-6) amidst its concerns that the product might be abused as a date-rape drug. Sodium oxybate was developed by Jazz Pharmaceuticals Inc as a treatment for fibromyalgia. The vote against the approval of the drug is a big blow to the pharmaceutical company who had expected a huge increase in sales once the drug was on the market.

Date Rape

Sodium oxybate contains a form of gamma hydroxybutyrate (GHB) a chemical with a reputation as a party drug, used to sedate women in order to rape them. The panelists admitted that the drug appears to alleviate the symptoms of fibromyalgia in some patients. But at the same time, the panelists were not at all convinced that the safeguards proposed by the company would be effective in protecting the public against the misuse of the drug. 

Baylor College of Medicine’s Dr. Thomas Kosten, a professor of psychiatry and addiction at the Houston institution said that the risk that the drug could be abused is “huge.” Furthermore, Kosten states that the drug carries the potential for serious complications. GHB, a liquid that is both colorless and tasteless, can induce coma and death if taken in high doses.

Illegal Misuse

However, several of the panelists encouraged Jazz not to shelve the medicine, since there is a significant need for new treatment options for fibromyalgia. Rather, some suggested a study on the long-term risks of the medication, while others pressed for more effective protective measures to prevent the illegal misuse of sodium oxybate.  Still other panelists said that Jazz should focus on proving that the drug is more effective than the three approved medical treatments for fibromyalgia that are now on the market.

In most cases, the FDA follows the recommendations of such panels, though a final decision is not due until Oct. 11. Market analysts commented on the fact that a vote of 20-2 is a very strong rejection. The vote was met with not a little surprise by market experts who had predicted sales of $300 million by the year 2015 for JZP-6.

Chief Executive of Jazz, Bruce Cozadd said he was disappointed with the vote but would still be meeting with FDA officials to discuss its reviews. Cozadd said that Jazz would be playing close attention to the input of the advisory panel as the company continues to try to focus on how best to help fibromyalgia sufferers with safe treatment options.