Setback for Pfizer drug Lyrica

Share this article:
In a setback for Pfizer, the FDA said it would classify its newly approved nerve pain drug Lyrica as a controlled substance.
Pfizer had been counting on Lyrica to offset declines in Neurontin, which saw patent expiration last year. But under the new controlled substance classification, Lyrica would be subject to the rules of the Drug Enforcement Agency and be more difficult to prescribe and dispense than generic Neurontin, known chemically as gabapentin.
Lyrica was approved to treat pain from nerves damaged by diabetes and shingles last week. The FDA is still reviewing the drug as an aid to managing epileptic seizures.
A Pfizer spokeswoman told The Wall Street Journal the launch date and price for Lyrica couldn't be determined until the DEA completes its review – a process that could take weeks or months. The spokeswoman declined to comment on what triggered the controlled substance classification.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.