Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly voted (20 to 2) against approving sodium oxybate (brand name Xyrem) for the treatment of fibromyalgia.
While most of the panel members agreed that the drug was effective for some FM patients, their concerns centered around its safety. Sodium oxybate, also known as gamma-hydroxybutyrate (GHB) is known to have been used as a date rape drug.
Some panel members expressed an interest in seeing additional studies measuring sodium oxybate's effectiveness against the other drugs already approved for fibromyalgia treatment. They felt it should only be approved if it could be shown to work better than the other medications or work for patients who were not helped by the other available drugs.
Dosing of sodium oxybate is different than most drugs. It is given in two separate doses. The patient falls asleep immediately after the first dose, but must wake up two to four hours later and take a second dose.
In two previous phase III clinical trials that included a total of more than 1,000 fibromyalgia patients, sodium oxybate significantly decreased pain and fatigue and improved daily function. It is currently approved for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy.
Sodium oxybate already has one of the most stringent REMS plans I've seen. It is classified as a schedule III drug and its distribution is restricted through the Patient Success Program. It can only be purchased from a central, mail-order pharmacy and patients are first required to read a letter and brochure as well as watch a video about the medication. In spite of these restrictions, Kathleen O'Neil, MD, from the University of Oklahoma College of Medicine, who chaired the meeting, said she thinks the REMS for sodium oxybate need to be strengthened.
The FDA is expected to make their final decision by October 11, 2010. Although they are not required to follow the recommendations of their advisory panels, the strong one-sided vote is bound to have an impact on their decision.
Jazz Pharmaceuticals, the manufacturers of Xyrem (sodium oxybate), have said they will continue to develop the drug as a possible treatment for fibromyalgia and will work with the FDA towards ultimate approval.
Personally, I'm not sure what else could be done to strengthen the REMS short of someone from the FDA coming to your home and watching you take the medication. I think the paranoia about patients possibly abusing their medications is getting out of control. The fact that anyone taking sodium oxybate has to use one central pharmacy virtually eliminates the ability of someone to doctor shop and fill more than one prescription. How much more control is possible?
I'd hate to see an effective treatment option rejected just because of excessive concerns about potential abuse. I have a feeling the term “date rape” spooked the panel so badly that despite the stringent REMS, they let their fears rule the day.
Source: Lowry, Fran. FDA Panel Says No to Sodium Oxybate for Fibromyalgia. Medscape Medical News. August 22, 2010.
Published On: August 25, 2010