Lyrica launches with professional education push
The launch had been delayed until the Drug Enforcement Agency could schedule the product, which is classified as a controlled substance.
Lyrica, one of four products Pfizer plans to launch this year in the U.S., is the first new drug to hit pharmacy shelves since the drug maker announced a six-month moratorium on direct-to-consumer advertising of new prescription medicines in August. Pfizer has pledged to educate physicians on the drug's benefits and risks before promoting it to the public.
"We're making sure that doctors are well-informed about a new medication before patients start any kind of conversations about it," Rebecca Hamm, a Pfizer spokeswoman, told MM&M.
She would not confirm whether a DTC component is planned beyond the six months.
The professional communication push has already started, and includes a site for healthcare professionals at Lyrica.com. Journal advertising also is planned, Hamm said.
The drug maker will also rely heavily on its vast sales force to provide disease and product education to a wide swath of the medical community that includes neurologists, pain management specialists, endocrinologists and primary care physicians who treat patients with diabetes.
The FDA approved Lyrica last December for managing two kinds of neuropathic pain: nerve pain associated with diabetes (DPN) and nerve pain associated with shingles (PHN). The product won approval as an adjunctive treatment of partial onset seizures in adults with epilepsy in June.
The indication for DPN (diabetic peripheral neuropathy) represents an advantage over predecessor Neurontin (gabapentin), which is approved for PHN and for treating partial seizures in adults and children, but not for DPN. Neurontin has been losing share to generic competition since going off patent last year.
"Representatives [will be] out talking to physicians and really helping to explain not only about Lyrica but in many cases helping to explain about diabetic peripheral neuropathy, a condition for which there haven't been many options...especially in the primary care arena," Hamm said.
Already approved in 47 countries outside the U.S., Lyrica is well known among key opinion leaders, said Ron Pantello, chief executive of Euro RSCG Life, which is handling the launch. "Now it's just a function of spreading the word."
Pfizer also says it's in the midst of launching acute macular degeneration drug Macugen; pulmonary arterial hypertension drug Revatio; and Zmax, an extended release form of antibiotic Zithromax.
IMS Health expects Lyrica to achieve more than $1 billion in sales.
But it first faces the hurdle of being classified as a controlled substance by the DEA, which could make it more difficult to prescribe and dispense than generic Neurontin.
"For the most part, every prescribing physician in the country does have a DEA number, so they are able to prescribe controlled substances," Hamm said.
But nurse practitioners and physician assistants--which together accounted for 4 percent of all prescriptions in 2004, according to IMS--are more restricted in their ability to prescribe these substances.
Individual state rules also may prohibit sales representatives from leaving samples of drugs which are scheduled as controlled substances.
New York is one, Hamm said, adding, "For the vast majority of the country, there are not those type of restrictions."
The DEA classified Lyrica as a Schedule V drug, meaning that it has the least potential for abuse. Other Schedule V drugs include cough medicines with codeine. The rule explaining the scheduling was issued July 28.
Common side effects of Lyrica include dizziness, sleepiness, dry mouth, swelling of hands and feet, blurred vision, weight gain and trouble concentrating.
"In terms of our commitment of bringing 20 new medicines to market in the next five years, this represents an important step forward," Hamm said.