First FDA Approval for FM Treatment Drug Expected by 2008

Pharmaceutical companies are “racing” to gain regulatory approval for their drugs to serve the virtually untapped Fibromyalgia market, according to an industry update from Reuters news dated January 7, 2007.

The contenders “are looking to seize on a market now dominated by older anti-depressants as well as painkillers and other drugs,” the report states. These competitors are mostly major players – the likes of Pfizer, Eli Lilly, and Forest Laboratories Inc. And they have their eyes on a market that the research firm Decision Resources predicts will reach $1 billion in less than a decade.

The race, of course, is to be first to win FDA clearance for use of their drugs specifically as Fibromyalgia treatments. And the winning approval is expected as early as 2008. Some FM-targeted drugs already have FDA approval for other applications, and are being prescribed “off-label” for some Fibromyalgia patients.

But until positive results with FM patients are produced via clinical trials and to the FDA’s satisfaction, the drug companies are barred from actively marketing their drugs as FM-specific therapeutics. Once the makers are able to market openly to consumers and the physician community, the FM market will be “a nice way to tack on $200 million to $300 million more in sales,” a Decision Resources spokesperson told Reuters.

High-profile examples of contenders in the FM therapy race include the following drugs for pain:

Pfizer’s pregabalin (Lyrica®)

Recently approved by the FDA to treat nerve pain and seizures, this drug has been progressing swiftly through the clinical trial process, as last reported in late November 2006. See “Major Trial Concludes Pregabalin (Lyrica®) Promising FM Pain Therapy,” at http://www.immunesupport.com/library/showarticle.cfm/id/7535

Next steps now in progress are that:

n FM patients who participated in this randomized, placebo-controlled, double-blinded trial are currently being recruited for a 12-week follow-up “open label safety trial” of pregabalin. That is, in the double-blinded phase of the trial, one randomly selected group of patients received a “placebo” or fake dose, but neither the patients nor those administering the doses knew which group was which until the study was completed. In the current phase, all patients will openly receive pregabalin.

n Pfizer is also seeking more than 700 other FM patients at 50 trial sites in 10 nations outside the U.S. - including Canada, the UK, and Australia. This 14-week Phase III trial will track both primary (pain) and secondary (sleep, fatigue, mood, etc.) outcomes of pregabalin therapy administered twice daily. It, too, will be randomized, placebo-controlled, and double blinded. For more information about the trial (Number NCT00333866) and a link for local contact information, visit the ClinicalTrials.gov site at http://clinicaltrial.gov/ct/show/NCT00333866?order=13

Eli Lilly’s duloxetine (Cymbalta®)

Duloxetine is a drug approved as an anti-depressant that regulates two brain transmitters, serotonin and norepinephrine. Lilly’s recent trial of duloxetine (Cymbalta®) for patients with chronic pain and/or major depression indicated that for the Fibromyalgia patients, “80 percent of the observed effect on pain is a direct analgesic effect rather than an indirect antidepressant effect.” See an abstract of the November 2006 article “Efficacy of duloxetine in painful symptoms: An analgesic or antidepressant effect?” at http://www.immunesupport.com/library/showarticle.cfm/id/7382

Other recent reports on Lilly’s duloxetine trials for FM pain include “Duloxetine Reduces Fibromyalgia Pain: Presented at the Annual Meeting of the American Academy of Pain Management,” at http://www.immunesupport.com/library/showarticle.cfm/id/7037

And three Phase III studies of duloxetine for treatment of Fibromyalgia pain focused on comparative dosages and safety are listed as “No Longer Recruiting Patients” at ClinicalTrials.gov. (The drug is also being studied as a potential therapy for patients with CFS, RLS, IBS, low back pain, and more.)

Forest Laboratories’ Milnacipran®

Another serotonin/norepinephrine regulating drug that like duloxetine has been approved as an anti-depressant and is now completing Phase III FM pain trials is Forest Laboratories’ Milnacipran®. See for example “Forest Laboratories, Inc. and Cypress Bioscience, Inc. to Commence Third Milancipran Phase III Trial” at http://www.immunesupport.com/library/showarticle.cfm/id/6932

Abuse-Resistant Opioids Next?

Meanwhile, some new modes of pain relief that may prove effective for Fibromyalgia patients’ pain are hurrying through the clinical trial process. Just one example is Remoxy® – the first of DURECT Corporation’s two Oradur®-based “abuse-resistant opioid pain medicines” – now in Phase III trials. See “Positive Phase I Results Reported for DURECT’s Second Abuse-Resistant Opioid Pain Medicine,” at http://www.durect.com/wt/durect/page_name/pr_1164847961