Bracing for impending competition to its big-selling Lyrica, Pfizer has won FDA approval for a longer-lasting version that could help defend its sales.
A once-daily tablet, Lyrica CR is now cleared to treat pain caused by shingles or diabetic peripheral neuropathy, though not for fibromyalgia as the original Lyrica formula is, according to a Thursday release.
Two out of three isn't bad, and the approvals could help Pfizer win current Lyrica patients over to the new formulation as cheap copycats near the U.S. market. More than a half-dozen generics makers have tentative approvals to sell copies of the original formulation, dosed two to three times daily.
To keep blockbuster franchises alive in the face of generic competition, drugmakers often roll out new, more convenient versions that can inspire patients to stick with the brand. A Pfizer representative didn't say whether the drugmaker believes current Lyrica patients would switch to Lyrica CR, but said in a statement that the med "was developed to offer patients an effective treatment option with the convenience of once-daily dosing." The drug should be available in January, he said.
Anything Pfizer can do to protect Lyrica sales will be critical. The nerve pain med generated $3.13 billion in the U.S. last year, a 26% climb over the year before. The company has been heavily promoting its med on TV and raising prices as its patent expiration nears. Last month, the drug topped industry TV ad spending, according to ad tracker iSpot.tv, overtaking AbbVie's anti-inflammatory blockbuster Humira.
Back in June, Pfizer raised the price on Lyrica and 90 other drugs, Financial Times reported. That followed a separate price hike early last year of 9.4%, according to Deutsche Bank analysts.
Lyrica's U.S. patent expires next December. Pfizer's representative reiterated that the new approval doesn't impact that expiration.
Switching patients to longer-acting versions of key medications has been a tried and true strategy for pharma companies who are expecting generic erosion. Then led by CEO Brent Saunders before the Allergan buy, Actavis previously tried to switch Namenda patients to patent-protected Namenda XR by removing the older version from the market. A court ended up blocking the strategy, but Actavis was able to switch a high number of patients without the maneuver.
In advance of generics to multiple sclerosis blockbuster Copaxone, Teva Pharmaceutical worked to switch patients to a longer-lasting version. That company now faces generic competition from Mylan, which won a Copaxone copycat approval last week.