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APS 2010: fibromyalgia newcomer seeks differentiation while prospective player draws nearer
Established drugs such as Cymbalta and Lyrica will serve to restrict uptake of the most recent entrant to the fibromyalgia market, Savella. Accordingly, data presented at this year's American Pain Society Annual Meeting indicate that Savella's marketing companies are endeavoring to differentiate the product from its key competitors in order to maintain uptake and drive sales.
The current fibromyalgia pipeline is small in comparison to other central nervous system conditions. Moreover, the past two years have witnessed a spate of project terminations and suspensions of fibromyalgia pipeline candidates including Neupro (rotigotine patch; UCB), esreboxetine (Pfizer), Pristiq (desvenlafaxine; Wyeth), AD-337 (Sosei Group) and pramipexole ER (Boehringer Ingelheim). Nevertheless, the presentation of encouraging Phase III data for JZP-6 (sodium oxybate; Jazz Pharmaceuticals/UCB) at this year's meeting of the American Pain Society (APS 2010) bolsters the expectation that a fourth treatment option will soon be available to US-based physicians treating this chronic pain condition.
New data highlight Savella
Having launched in the US in April 2009 following FDA approval in January 2009, Savella (milnacipran) - a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI) - represents the most recent entrant to the fibromyalgia market. Cypress Bioscience and Forest Laboratories developed the drug under a North American license from Pierre Fabre.
A Forest and Cypress-sponsored study presented during APS 2010 examined the efficacy and tolerability of milnacipran (50mg BID) when added to pregabalin (150mg BID or 225mg BID) in fibromyalgia patients who experienced an incomplete response to pregabalin. Results demonstrated that patients receiving milnacipran and pregabalin experienced a significantly greater reduction in pain than patients treated with pregabalin alone. In addition, Patient Global Impression of Change (PGIC) responder rates were significantly greater in patients treated with milnacipran and pregabalin than pregabalin alone. The study investigators concluded that in fibromyalgia patients experiencing an incomplete response to pregabalin, milnacipran was both tolerable and effective in improving patient assessment of global status and reducing pain.
The conduct of this combination trial represents a significant strategic ploy by Forest and Cypress as they seek to identify methods that will differentiate Savella from its key competitor, Cymbalta (duloxetine; Eli Lilly), which is a similar SNRI. In view of pregabalin's and milnacipran's complementary mechanisms of action, the reported clinical benefits of combined treatment are unsurprising. Although payers are likely to be reluctant to reimburse a combination therapy that includes two branded drugs, Datamonitor believes that the positive results of the combination study place Savella in a strong position in the overall fibromyalgia treatment algorithm by addressing the requirements of the many patients who do not respond to Lyrica alone.
Positive trial results bode well for Jazz
Marketed under the brand name Xyrem, sodium oxybate (an oral liquid formulation of gamma hydroxybutyrate) is currently approved for the treatment of narcolepsy-associated cataplexy. Jazz Pharmaceuticals, in collaboration with its EU partner UCB, is developing sodium oxybate under the codename JZP-6 for the treatment of fibromyalgia. On February 18, 2010, the FDA accepted Jazz Pharmaceuticals's NDA for JZP-6 for the treatment of fibromyalgia. The candidate remains in Phase III development for this indication in the EU.
Jazz Pharma's NDA submission was based on a clinical development program that included results from two Phase III clinical trials. At APS 2010, investigators reported results from a Phase III trial which assessed the effects of sodium oxybate on fibromyalgia symptomatology in 548 patients. Results showed that at week 14, the two doses of sodium oxybate under study (4.5g/night and 6g/night) led to a significantly greater response for the primary efficacy endpoint compared with placebo. A 30% pain reduction at week 14 was achieved by 54.2% (4.5g) and 58.5% (6g) compared to 35.2% for placebo. Furthermore, the proportion of participants with a 50% reduction in pain was significantly higher in both sodium oxybate groups relative to placebo. Treatment with sodium oxybate also resulted in clinically meaningful improvements in function and quality of life, and the drug was generally well-tolerated.
These data were not new, having been previously announced at the 62nd Annual Meeting of the American Academy of Neurology in April 2010, and at the American Academy of Pain Management meeting in October 2009. Nevertheless, the significant reduction in pain and improvement in function and quality of life demonstrated in the Phase III trial bodes well for regulatory approval of JZP-6 in fibromyalgia. Based on a standard 10-month review, the target date for the FDA to complete its review of the NDA under the Prescription User Fee Act is October 11, 2010. Assuming a positive regulatory response, Datamonitor anticipates a potential US launch date for JZP-6 in fibromyalgia in Q4 2010. Upon approval, Datamonitor believes JZP-6's market share will be derived from a number of sources including drugs that tackle disturbed sleep as well as those that treat the pain characteristics of fibromyalgia. This includes some patients switching over from off-label hypnotic agents, a small number of patients currently receiving Lyrica (pregabalin; Pfizer), as well as from patients currently prescribed any one of a number of other drug classes that continue to make up a large proportion of the fibromyalgia market volume. While the Phase III data for JZP-6 to date are encouraging, Datamonitor believes that the negative perception surrounding the drug's formulation, its prescription constraints and abuse potential will all prevent the drug from generating revenues at the level seen with current approved treatments.
• Forecast Insight: Fibromyalgia - Regulatory caution threatens EU market expansion priced $15,200
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