FDA Approvals: Campral, Cymbalta, Truvada, and Epzicom

Yael Waknine

August 05, 2004

Aug. 5, 2004 — The U.S. Food and Drug Administration (FDA) has approved acamprosate calcium for the maintenance of alcohol abstinence, duloxetine HCl for the treatment of major depressive disorder, two fixed-dose combination treatments for HIV-1 infection, and an injectable filler for facial lipoatrophy in patients with HIV.

Acamprosate (Campral) for Maintenance of Alcohol Abstinence

On July 30, the FDA approved acamprosate calcium tablets (Campral, made by Lipha Pharmaceuticals, Inc.) for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. The drug is intended for use as part of a comprehensive management program that includes psychological support.

The approval was based on results of multiple clinical studies showing that acamprosate was more effective than placebo in maintaining abstinence in detoxified patients. The medication may not be effective in actively drinking patients or in those abusing other substances in addition to alcohol.

Adverse events included headache, diarrhea, flatulence, and nausea.

Duloxetine (Cymbalta) for Major Depressive Disorder

On Aug. 4, the FDA approved duloxetine HCl capsules (Cymbalta, made by Eli Lilly and Co.) for the treatment of major depressive disorder in adults. Duloxetine is a balanced reuptake inhibitor of both serotonin and norepinephrine. The recommended daily dose is 60 mg.

The approval was based on results of four studies involving 875 patients diagnosed with major depressive disorder and given duloxetine (40-120 mg/day) or placebo for eight or nine weeks. Duloxetine was superior to placebo in improving Hamilton Depression Rating Scale scores in all four studies. Doses higher than 60 mg per day did not show added benefit.

Adverse events included nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating.

Indications for duloxetine currently under study include stress urinary incontinence and diabetic neuropathic pain.

Emtricitabine and Tenofovir Combination (Truvada) for HIV-1

On Aug. 2, the FDA granted an accelerated approval for a fixed-dose combination tablet (Truvada, made by Gilead Sciences) consisting of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Emtriva and Viread, both made by Gilead Sciences), to be taken once daily in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

The approval was based on data showing therapeutic equivalence between the combination product and the combined individual agents.

Abacavir and Lamivudine Combination (Epzicom) for HIV-1

On Aug. 2, the FDA approved a fixed-dose combination tablet (Epzicom, made by GlaxoSmithKline) of abacavir sulfate 600 mg and lamivudine 300 mg (Ziagen and Epivir, both made by GlaxoSmithKline), to be taken once daily in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

The approval was based on results from a large study showing that once-daily dosing of abacavir had antiviral effects similar to that of twice-daily dosing in combination with lamivudine and with efavirenz.

Sculptra Injectable Filler for Facial Lipoatrophy in HIV Patients

On Aug. 3, the FDA approved an injectable filler (Sculptra, made by Aventis subsidiary Dermik Laboratories) for use in correcting facial lipoatrophy in HIV-infected patients. The filler is an injectable form of poly-L-lactic acid, a biocompatible and biodegradable polymer that has been widely used in dissolvable stitches, bone screws, and facial implants.

The approval was based on a review of clinical studies involving 277 HIV-infected patients (a majority of them were white men aged 41-45 years) with severe lipoatrophy. Patients were given three to six injections at two-week intervals and followed for two years.

The filler produced significant increases in skin thickness, adding volume to facial tissue and restoring shape to facial areas lacking fat. Patients reported increased quality of life and a reduction in depression and anxiety as a result of the treatment. Adverse events included nodules, redness, swelling, and bruising at the injection site.

Repeat injections may be required to maintain the effect after initial treatment. As a condition for approval, the company will be conducting a long-term efficacy study to include women and patients with darker skin types.

The product is marketed in Europe as a wrinkle filler (New-Fill), but this indication is not approved in the U.S.

Reviewed by Gary D. Vogin, MD

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