FDA Approves New Formula for Pregabalin

The US Food and Drug Administration (FDA) yesterday announced that it approved a new formula for pregabalin (Lyrica, Pfizer) extended-release tablets for the once-daily treatment of neuropathic pain associated with diabetic peripheral neuropathy (dDPN) as well as postherpetic neuralgia (PHN) management.

The drug did not receive an indication for fibromyalgia management, the third of three indications that Pfizer sought in its application. The decision was made based on data from a phase 3 trial including 801 patients with PHN, comparing the treatment with placebo. The data on PHN being accepted for both PHN and dDPN due to their similar nature as peripheral neuropathic pain conditions.

Results from the phase 3 trial showed a 50% improvement in pain intensity by 73.6% of patients in the pregabalin arm, compared to 54.6% in the placebo group.

“LYRICA CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” James M Rusnak, MD, PhD, the chief development officer of Internal Medicine, Pfizer Global Product Development, said in a statement. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.”

The trial took place over 19 weeks, with 6 weeks in a single-blinded period, followed by 13 weeks in a double-blinded period. The PHN data was considered supportive for both PHN and sDPN, as both conditions are peripheral neuropathic pain conditions.

Dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain were the most common adverse reactions to the treatment.

This approval comes just before the generics for the treatment begin to become available, with multiple copycats planning on making an appearance to the market within the next year.