FDA Approvals: Nevanac, Sugar-Free Actiq, Quinine Sulfate

Yael Waknine

September 15, 2005

Sept. 15, 2005 — The U.S. Food and Drug Administration (FDA) has approved nepafenac 0.1% ophthalmic suspension for the treatment of pain and inflammation associated with cataract surgery; a sugar-free formulation of oral transmucosal fentanyl citrate for the management of breakthrough cancer pain; and quinine sulfate 324-mg capsules for the treatment of uncomplicated Plasmodium falciparum malaria.

Nepafenac 0.1% Ophthalmic Suspension (Nevanac) for Post-Cataract Surgery Pain and Inflammation

On Aug. 19, the FDA approved nepafenac 0.1% ophthalmic suspension (Nevanac, made by Alcon, Inc.) for the treatment of pain and inflammation associated with cataract surgery.

According to a company news release, the nonsteroidal anti-inflammatory prodrug has target-specific activity designed to rapidly penetrate ocular tissues, thereby maximizing therapeutic efficacy and potentially improving patient outcomes.

The approval was based on a six-month priority review of data from two multicenter studies in 680 patients. Study results showed that patients treated with nepafenac were less likely to have ocular pain on the first postsurgical day (80% vs 50%) and at two-week follow-up (95% vs 45%). Those receiving nepafenac were also more likely to show no clinically significant signs of inflammation at two weeks compared with placebo (91% vs 47%).

The most commonly reported ocular adverse events after cataract surgery occurred with similar frequency (5% - 10%) in the active-treatment and placebo groups and may have been a consequence of the procedure; these included capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.

Treatment with nepafenac ophthalmic suspension (one drop in the affected eye[s] three times daily) should be initiated on the day before surgery and continued through the first two weeks of the postoperative period.

Sugar-Free Fentanyl Citrate Lozenge (Actiq) for Breakthrough Cancer Pain

On Sept. 9, the FDA approved a sugar-free formulation of oral transmucosal fentanyl citrate (Actiq, made by Cephalon, Inc.) for the management of breakthrough pain in patients with malignancies who are already receiving and are tolerant of opioid therapy for their underlying persistent cancer pain.

The formulation is bioequivalent to the currently available lozenge of the same name, which it will be replacing on the market.

Quinine Sulfate Capsules Reintroduced for the Treatment of Uncomplicated Malaria

On Aug. 12, the FDA approved quinine sulfate 324-mg capsules (made by Mutual Pharmaceuticals Co.) for the treatment of uncomplicated Plasmodium falciparum malaria.

The approval was based on a review of clinical studies demonstrating the efficacy of quinine in geographical areas where resistance to chloroquine has been documented.

The FDA notes that quinine therapy is not indicated for the prevention of malaria, or for its treatment in patients with severe or complicated forms of the disease. It is also not indicated for the treatment of nocturnal leg cramps.

Over-the-counter quinine sulfate 260-mg capsules and 200- and 325-mg tablets were previously approved by the FDA for the prevention and treatment of malaria. They were withdrawn from the market in 1995 due to reports of potentially serious and life-threatening adverse events associated with their use in the treatment of malaria and off-label use in the treatment of nocturnal leg cramps.

Reviewed by Gary D. Vogin, MD

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