Pfizer Announces Phase III Clinical Failure of Lyrica in PGTC Seizures as Generic Competition Looms

Pfizer recently announced that a Phase III study evaluating Lyrica (pregabalin) as an adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy failed to meet its primary endpoint.

This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of two doses of Lyrica as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in patients aged 5 to 65 years with epilepsy. The study was conducted at 70 clinical sites across 21 countries and enrolled 219 patients. Patients were randomized in a 1:1:1 ratio to receive either placebo or one of two fixed-dose regimens of Lyrica administered twice daily: 5 mg/kg/day (7 mg/kg/day for subjects weighing <30 kg; 300 mg/day for subjects aged ≥17 years) or 10 mg/kg/day (14 mg/kg/day for subjects weighing <30 kg; 600 mg/day for subjects aged ≥17 years).

The results showed that, compared with placebo, neither dose of Lyrica significantly reduced the frequency of PGTC seizures. In terms of safety, the findings were comparable to the known safety profile observed in previous clinical studies of epilepsy in pediatric and adult patients. The most common adverse effects were dizziness, headache, and somnolence.

This study fulfills a postmarketing commitment to the U.S. FDA. The Lyrica pediatric epilepsy program comprises six studies in patients with epilepsy, five of which have been completed.

Epilepsy is a chronic condition characterized by recurrent, unprovoked seizures, affecting both adults and children. It is estimated that there are approximately 65 million people with epilepsy worldwide, including over 3 million in the United States, of whom 470,000 are children. PGTC seizures, also known as grand mal seizures, are the most common type of generalized seizure and involve loss of consciousness.

Lyrica is an antiepileptic and analgesic medication approved for multiple indications in more than 130 countries and regions worldwide. In the United States, Lyrica is indicated for the treatment of fibromyalgia, diabetic neuropathic pain, neuropathic pain associated with spinal cord injury, and postherpetic neuralgia in adults. Additionally, Lyrica is approved as adjunctive therapy for partial-onset seizures in patients with epilepsy aged 4 years and older.

Lyrica is a blockbuster product from Pfizer, with steady sales growth since its launch. In 2018, its global sales reached $4.97 billion, of which the U.S. market contributed $3.5 billion. In the United States, Lyrica’s patent was originally set to expire on December 30, 2018, but its patent protection was extended by six months due to the pediatric epilepsy program. Generic versions of the drug are expected to enter the U.S. market by the end of June this year.

Compared with biosimilars, the impact of generic small-molecule drugs on brand-name drugs has been catastrophic. Once generic small-molecule drugs enter the market, sales of brand-name drugs will experience a precipitous decline, with first-year revenue losses of at least 50%. GlobalData predicts that following the launch of generics, Lyrica’s sales will drop from nearly $5 billion in 2018 to $950 million in 2024. (Compiled by Sina Medicine/newborn)

Reference Source: Pfizer Announces Top-Line Results from Phase 3 Trial of LYRICA (pregabalin) in Primary Generalized Tonic-Clonic Seizures

(Editor:Wang Xing）

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