JZP-6 No Threat To Existing Treatments
Jazz Pharmaceuticals has already filed an application with the FDA for its fibromyalgia treatment JZP-6 (sodium oxybate oral solution). That means there’s a good chance that this new treatment will be the fourth medication approved to treat fibromyalgia syndrome (FMS). Be that as it may, JZP-6 is unlikely to threaten sales of the other three fibromyalgia treatments on the market.
That’s because sodium oxybate is a liquid form of ecstasy, which is a well-known recreational drug with a serious potential for abuse. Also, the drug is not going to be in wide supply and will come with a hefty price tag affixed. On the other hand, in two separate Phase III trials, sodium oxybate gave significant pain relief, reduced fatigue, and improved the daily functioning, sleep quality, and global impression of change in fibromyalgia patients.
Fibromyalgia is a debilitating condition causing widespread muscle pain and fatigue which affects mostly women. Around 6 million US residents suffer from FMS. But the condition is little understood.
Thus far, three drugs have been approved by the FDA for the treatment of FMS: Lyrica (Pfizer’s pregabalin), Cymbalta (Eli Lilly’s and Boehringer Ingelheim’s duloxetine), and Savella (Pierre Fabre and Forest’s milnacipran). These drugs only received approval during the past two and a half years. Because of the entrance of these treatments on the market, a greater awareness of fibromyalgia has grown and developed.
The new kid on the fibromyalgia medication block, sodium oxybate, is gamma-hydroxybutyrate in sodium salt form. Gamma-hydroxybutyrate is known as an endogenous neurotransmitter as well as a metabolite of GABA.
Already marketed as Xyrem for treating cataplexy, a sudden temporary loss of muscle tone and a symptom associated with narcolepsy, the FDA classifies this drug as a controlled substance (Schedule III drug). By law, Xyrem is labeled with a black box warning stating that the drug depresses the central nervous system, carries the potential for abuse, and cannot be used in tandem with alcohol or other central nervous system depressants.
Xyrem has earned a decent reputation with sleep experts and this should boost the success of JZP-6 as a fibromyalgia treatment. But marketing experts predict that due to the black box warning, a certain stigma will be attached to the use of JZP-6, limiting its potential value as a treatment for fibromyalgia. Restricted distribution plus a high price tag will tend to limit the potential of sodium oxybate as a widely-used treatment for fibromyalgia.
Pharmaceutical companies are looking at a liquid form of ecstasy to help treat fibromyalgia. While that may not happen within the next several months, ecstasy remains to be a popular drug of choice among many, which can cause ecstasy overdose with very unpleasant symptoms.