In the first 9 months of 2007, Pfizer, the maker of LyricaTM (generic name pregabalin – which in June 2007 became the first prescription drug to receive FDA approval specifically for treatment of Fibromyalgia) reportedly spent just under $40 million on Lyrica’s advertising. Meanwhile, worldwide sales of Lyrica increased 50% in 2007, to $1.8 billion, the New York Times reported in January. Lyrica, an anticonvulsant, has also been prescribed with FDA approval since 2005 to treat diabetic and post-shingles nerve pain and seizures.
As for the future, according to a Medical Marketing & Media news report, “New therapies are expected to grow the Fibromyalgia market from under $400 million in 2006 to $2 billion by 2016.” In addition to Lyrica, “the FDA is set to decide on Eli Lilly’s CymbaltaR in Fibromyalgia on or before June 2008, while Forest Labs and Cypress filed milnacipran for that indication on December 31st .* Two other compounds are in late-stage clinical development. And other hopefuls are entering the race.”
Marketing Strategies Founded On Awareness-Building
“Do you think having FDA-approved drugs will improve respect, treatment, and results for patients, or just make money for drug companies?” a patient asked FM pain researcher Dr. Daniel Clauw, MD, in his recent Live Chat Q&A on ImmuneSupport.com. “Absolutely. Drug companies are already spending a lot of money educating physicians about FM,” Dr. Clauw responded. “When physicians better understand diseases they treat them better. So I think that the drugs themselves will be of benefit, but that the education campaigns they disseminate regarding FM will be at least as helpful as the drugs. Some of the companies are also developing very good patient education and self-management programs for FM too. So I’m OK with the companies making money if they help patients.” As for patient results, Dr. Clauw noted, “The data suggest that Lyrica, like the other drugs that will likely be FDA approved for FM, works well in about 30% to 40% of patients who take it.”
A “Risk to Benefit Ratio”
Specifically, about 30% of patients in clinical trials said their pain improved by “at least half” vs. 15% of those taking placebos. The average improvement for all participants was 2 points on a 10-point scale, vs. 1 point for placebo. Potential side effects identified in the trials include weight gain/edema (an average 7% gain over 12 weeks in 9% of patients), dizziness, and sleepiness. But severe pain can be capacitating, and “the overall risk-to-benefit ratio” supports the drug’s approval, senior FDA officials reportedly decided.
Much of the advertising for Lyrica has been direct-to-consumer on TV, websites, and magazines, the MM&M report notes. It has included unbranded “condition-awareness efforts” developed collaboratively with the National Fibromyalgia Association that feature Fibromyalgia patients speaking about their experiences, followed by initiation of branded ads that employ essentially the same messages. A strong indication that the awareness efforts are “resonating,” industry watchers say.
“What’s going to happen with Fibromyalgia is going to be the exact thing that happened to depression with ProzacTM,” Dr. Clauw has commented. “These are legitimate problems that need treatments.”
* Cymbalta (duloxetine) is a selective serotonin and norepinephrine reuptake inhibitor (selective SNRI) that is FDA approved for treatment of major depressive disorder. The theory is that it increases the activity of these two neurotransmitters, which somehow affects “the volume of messages about pain between the body and the brain” and communication of messages affecting mood. Milnacipran is a norepinephrine serotonin reuptake inhibitor (NSRI) also studied for treatment of major depression and chronic pain. Reports in the medical literature have tracked the progress of FM trials for these and other drugs for a number of years.
Note: This information has not been evaluated by the FDA. It is generic and is not intended to prevent, diagnose, treat, or cure any disease. It is very important that you make no change in your healthcare plan without researching and discussing it in collaboration with your professional healthcare team.