FDA Approvals: Lyrica, Lunesta, Zylet, Enjuvia, PTC 124

Yael Waknine

January 07, 2005

Jan. 7, 2004 — The U.S. Food and Drug Administration (FDA) has approved pregabalin capsules for the management of neuropathic pain associated with diabetic peripheral neuropathy, and postherpetic neuralgia; eszopiclone tablets for sleep induction and maintenance; loteprednol etabonate 0.5% plus tobramycin 0.3% ophthalmic suspension for steroid-responsive inflammatory ocular conditions accompanied by a superficial bacterial ocular infection, or risk thereof; 0.3-mg and 0.45-mg tablet strengths of synthetic conjugated estrogens, B; and an orphan drug for cystic fibrosis caused by a gene nonsense mutation.

Pregabalin (Lyrica) for Neuropathic Pain Associated With Diabetes and Shingles

On Dec. 30, the FDA approved pregabalin capsules (Lyrica, made by Pfizer), for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN), and postherpetic neuralgia (PHN).

Pregabalin is the first drug to be approved by the FDA for both of these indications, which are distinctly different from arthritis or musculoskeletal pain. According to a company news release, the drug will likely be classified as a controlled substance in a category signifying a relatively low potential for misuse or abuse.

The approval was based on the results of six double-blind clinical trials, showing that treatment with pregabalin significantly reduced pain in patients with DPN and PHN. Pain relief was reported as early as the first week of treatment in some patients, and was sustained over the three-month trials.

The most common adverse events associated with pregabalin use included dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain and concentration/attention difficulties.

Pregabalin was approved in the European Union on July 6, 2004, for the treatment of peripheral neuropathic pain and as adjunctive therapy for partial seizures in patients with epilepsy. An indication for the adjunctive treatment of partial seizures is currently under review by the FDA.

Eszopiclone (Lunesta) for Sleep Induction and Maintenance

On Dec. 15, the FDA approved eszopiclone tablets (Lunesta, formerly known as Estorra; made by Sepracor, Inc.), for the treatment of insomnia and for sleep maintenance.

The approval was based on the results of 6 placebo-controlled trials involving 2100 subjects aged 18 to 86 years with chronic and transient insomnia. Two of these trials were in elderly patients (n = 523). At the recommended adult (2- to 3-mg) and elderly (1- to 2-mg) doses, eszopiclone administered at bedtime significantly decreased sleep latency and improved measures of sleep maintenance.

The FDA's decision to not limit the indication of eszopiclone to short-term use was based on the results of a six-month double-blind placebo-controlled trial demonstrating its long-term safety and efficacy.

The FDA notes that sleep disturbances that do not remit after 7 to 10 days of treatment may be caused by underlying physical and/or psychiatric disorders, and should be evaluated by a physician.

Further uses of eszopiclone are currently under investigation by the company, including the treatment of insomnia in patients suffering from depression or pain, and in women experiencing the effects of perimenopause.

Novel Combination Loteprednol Etabonate/Tobramycin Eye Drops (Zylet)

On Dec. 15, the FDA approved loteprednol etabonate 0.5% plus tobramycin 0.3% ophthalmic suspension (Zylet, made by Bausch & Lomb), for the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated, accompanied by a superficial bacterial ocular infection or risk thereof.

According to a company news release, the product is intended to provide power and protection for a wide range of patients, including steroid responders, ocular hypertensives, and those with glaucoma. The eye drops will be available in 2.5-, 5-, and 10-mL sizes.

0.3-mg and 0.45-mg Doses of Synthetic Conjugated Estrogens (Enjuvia) Available

On Dec. 21, the FDA approved 0.3-mg and 0.45-mg tablet strengths of synthetic conjugated estrogens, B (Enjuvia, made by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc.).

Larger doses (0.625-mg and 1.25-mg) were approved in May, 2004. The conjugated estrogen product is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Orphan Drug for Cystic Fibrosis Due to Gene Nonsense Mutation (PTC 124)

On Dec. 9, the FDA approved orphan drug designation for PTC 124 (made by PTC Therapeutics), allowing its use in the treatment of cystic fibrosis (CF) caused by a gene nonsense mutation.

Orphan drug designation is intended to promote the development of products that may offer therapeutic benefit in diseases with a low prevalence (< 200,000/year) in the U.S. It is estimated that CF is caused by a gene nonsense mutation in approximately 10% of 30,000 U.S. patients afflicted with the disease.

The approval was based on preliminary results of phase 1 studies in healthy volunteers, showing that the drug is orally bioavailable and well tolerated. According to a company news release, phase 2 trials are expected to begin in the first half of 2005, pending FDA approval.

Reviewed by Gary D. Vogin, MD

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