JZP-6 (Sodium Oxybate), a new drug for the treatment of fibromyalgia has been turned down by the Food and Drug Administration (FDA) in a response letter to an NDA (new drug application), saying that in its present form it cannot approve the new compound. The FDA response letter includes several issues, including better patient population data from trials, safety data, and proposed REMS (Risk Evaluation and Mitigation Strategy). Fibromyalgia is a syndrome (a collection of symptoms) which is long-lasting (chronic). Although it is frequently referred to as an arthritis-related condition, there is no joint damage or inflammation; neither is there any damage to muscles or other tissues. However, the patient experiences pain, sometimes severe as in arthritis, and also fatigue, headaches, irregular sleep patterns, painful periods in women, tingling and numbness in limbs and hands and feet, sensitivity to heat or cold, and occasionally fibro fog (memory problems and/or cognitive problems). Fibromyalgia can undermine a sufferer's ability to go about their daily activities. It is seen as a rheumatic condition; one that causes joint and soft tissue pain.
In a public statement, Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals, said:
We have requested a meeting with FDA in order to discuss and clarify the contents of the CRL and will then evaluate our next steps for JZP-6. We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA.
The main gist of the FDA response was that the drug requires more trials before the Agency could proceed. An FDA Advisory Committee had said in August that there were some concerns regarding potential abuse and/or misuse of the medication.
JZP-6 is currently sold under the brand name Xyrem for the treatment of cataplexy associated with narcolepsy and Excessive Daytime Sleepiness associated with narcolepsy. Jazz Pharmaceuticals wanted to market the product under the brand name Rekinla for the treatment of fibromyalgia.
When weighing the risks versus the benefits, the FDA Committee voted 2 to 20 against approval for the treatment of fibromyalgia.
Three products aimed at treating fibromyalgia have been approved by the FDA since 2007, Lyrica (Pfizer Inc.), Cymbalta (Eli Lilly & Co.) and Savella (Forest Labs and Cypress Bioscence).
Sources: FDA, Jazz Pharmaceuticals
Written by Christian Nordqvist