Pregabalin (Lyrica) not approved for fibromyalgia by the EMEA

lyrica Pregabalin (Lyrica) is an anticonvulsant drug derived from gabapentin, approved in the European Union and in the US in 2004. Currently, it has well defined indications:

  • Neuropathic pain.
  • Epilepsy in patients who have partial seizures that cannot be controlled with their current treatment.
  • Generalized anxiety disorder.

In June 21, 2007; the US Food and Drug Administration approved Lyrica as the first drug for the treatment of fibromyalgia, a year later duloxetine (Cymbalta) became the second.

On 23 April 2009, the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of an extension of indication that would include fibromyalgia treatment as a new indication for Lyrica.

Pfizer requested a re-examination of the opinion. After considering the grounds for this request,
the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation
on 23 July 2009.

The CHMP was concerned that the benefits of Lyrica in fibromyalgia had not been shown in either the short or the long term. There were no consistent or relevant reductions in pain or other symptoms in the short-term studies, and the maintenance of Lyrica’s effect was not shown in the longer study. The Committee was also concerned that the safety and effectiveness of Lyrica had not been shown in patients from the EU.

Bottom line:

EMEA didn’t approve an extension of indication for Lyrica to include the treatment of fibromyalgia.

Other approved indications (neuropathic pain, generalized anxiety disorder, epilepsy) for Lyrica remain with no changes.

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