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The European Commission has approved pregabalin capsules (Lyrica drug, Pfizer) to treat Generalized Anxiety Disorder (GAD) in adults. About 5% of people experience GAD at some point in their lives.

This approval was based on five randomized, double-blind clinical trials involving more than 2,000 patients. As early as the first week of treatment, it provided relief for emotional symptoms (e.g., depression and panic) and physical symptoms (e.g., headaches and muscle aches).

In the U.S., generic pregabalin is indicated for the management of diabetic peripheral neuropathy and postherpetic neuralgia and as an adjunctive therapy for partial-onset seizures. It is an alpha₂-delta ligand that appears to calm hyperexcited neurons.

Lamotrigine drug (Lamictal generic) tablets have been approved for patients with primary generalized tonicclonic (grand mal) seizures. With this indication, lamo-trigine can now be used as add-on therapy to treat children two years of age or older as well as adults.

This new use marks the fifth FDA approval for this medication in epilepsy treatment, making it one of the few antiepileptic drugs with established efficacy in a broad spectrum of seizure types, including partial and generalized seizures. It is also approved as maintenance therapy for adults with bipolar I disorder.

Grand mal seizures occur in approximately 20% of patients with epilepsy, usually without warning.

After a priority review, the FDA has approved pregabalin (Generic Lyrica, Pfizer) capsules CV (Schedule V) for the management of fibromyalgia. Characterized by chronic widespread pain that can be relentless, fibromyalgia is usually accompanied by poor sleep, stiffness, and fatigue; patients also experience deep tenderness, soreness, and flu-like aches.

Pregabalin binds to a specific protein within overexcited nerve cells and helps to calm damaged nerves. This is thought to reduce the level of pain.

Pregabalin medication is also approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia and for the adjunctive therapy for adults with partial-onset seizures.

The FDA has approved GlaxoSmith-Kline’s extended-release lamotrigine tablets (generic Lamictal XR) as once-daily, addon therapy for epilepsy patients 13 years of age or older with partial-onset seizures.

During a 19-week study, more patients who took this agent had a significant reduction in seizure frequency compared with patients receiving placebo. The patients in the study had been having seizures that were inadequately controlled with one or two antiepileptic drugs.

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Mylan Pharmaceuticals has received approval for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle) in strengths of 15 mg and 25 mg. The capsules are the generic version of Janssen/Ortho-McNeil’s anti-convulsant Topamax Sprinkle Capsulesin dosages of 15 and 25 mg.

Sources: Mylan; PharmaLive, October 15, 2009, www.pharmalive.com