FDA Approvals: Mucotrol, Clindesse, MultiHance, and Others

Yael Waknine

December 16, 2004

Dec. 16, 2004 — The U.S. Food and Drug Administration (FDA) has approved a concentrated oral gel wafer for the management and relief of oral lesion pain, a new formulation of clindamycin phosphate 2% cream for single-dose treatment of bacterial vaginosis, a generic formulation of didanosine delayed-release capsules, a gadolinium-based contrast agent for magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults, and a hydrofluoralkane-propelled formulation of ipratropium bromide inhalation aerosol.

Mucotrol Oral Gel Wafer Relieves Pain of Oral Lesions

On Nov. 24, the FDA approved a concentrated oral gel wafer (Mucotrol, made by Belcher Pharmaceuticals, Inc., a subsidiary of GeoPharma, Inc.), indicated for the management and relief of pain associated with oral lesions of various etiologies, including oral mucositis/stomatitis resulting from chemotherapy or radiotherapy; irritation due to oral surgery; traumatic ulcers caused by braces, ill-fitting dentures, or disease; and diffuse apthous ulcers.

The 2.2 gram wafer contains compressed powder and slowly dissolves in the mouth to form a soothing and protective layer over mucosal lesions.

Clindamycin Phosphate 2% Cream (Clindesse) Treats Bacterial Vaginosis in One Dose

On Nov. 30, the FDA approved a new formulation of clindamycin phosphate vaginal cream, 2% (Clindesse, made by KV Pharmaceutical Company), for the single-dose, topical treatment of bacterial vaginosis in non-pregnant women.

The proprietary VagiSite bioadhesive drug delivery technology allows single-dose treatment of bacterial vaginosis and its symptoms with an efficacy similar to that of 7-day topical clindamycin phosphate regimens, as demonstrated in clinical trials.

Use of the 1-dose regimen resulted significantly increased patient compliance, as compared with the 7-day regimen of clindamycin phosphate cream (95% vs. 65%).

Commonly reported adverse events included vaginosis fungal (14.1%), vulvovaginal pruritus (3.3%), and headache (2.7%).

FDA Approves Generic Version of Videx EC (Didanosine Delayed-Release Capsules)

On Dec. 3, the FDA approved didanosine delayed-release capsules (made by Barr Pharmaceuticals, Inc; generic version of Videx EC, made by Bristol-Myers Squibb) in 200-, 250- and 400-mg strengths.

The approval was based on the results of studies showing the two versions to be bioequivalent, and therefore therapeutically equivalent.

According to a company news release, the FDA granted expedited review of the abbreviated new drug application (ANDA) under the President's Emergency Plan for AIDS Relief (PEPFAR). The cost-effective generic version of didanosine is intended to allow wider patient access to the drug.

Didanosine delayed-release capsules are indicated for use in combination with other antiretroviral agents to treat HIV infection in adults.

Gadobenate-based Contrast Agent (MultiHance) Improves Lesion Visualization in CNS MRI

On Dec. 3, the FDA approved gadobenate dimeglumine (Gd-BOPTA) injection, 529 mg/mL (MultiHance, made by Bracco Diagnostics) for use as a contrast agent in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults, to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues.

The gadolinium-based agent features a weak and highly reversible interaction with serum proteins that increases relaxivity, resulting in improved signal intensity and image resolution for lesion visualization.

The approval was based on the results of clinical trials involving 560 adults suspected of having brain or spine lesions, showing that use of the agent significantly improved lesion detection and the degree of lesion border delineation, internal morphology visualization, and contrast enhancement, compared with non-contrast MR imaging.

Gadobenate dimeglumine injection was approved in October for use in Canada. It was previously approved for use in the European Union with the additional application of focal liver disease MRI.

CFC-Free Formulation of Ipratropium Bromide (Atrovent HFA) Protects the Ozone Layer

On Nov. 17, the FDA approved a chlorofluorocarbon (CFC)-free formulation of ipratropium bromide in a metered-dose inhaler (Atrovent HFA inhalation aerosol, made by Boehringer Ingelheim Pharmaceuticals, Inc.). The bronchodilator is indicated in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The breath-activated meter uses hydrofluoralkanes as propellants, replacing the CFCs that are harmful to the ozone layer of the Earth's atmosphere. The new formulation was developed in response to the Montreal Protocol on Substances that Deplete the Ozone Layer, a global agreement that requires the removal of ozone-depleting substances including CFC propellants.

The approval was based on the results of clinical trials showing that the CFC-free formulation and CFC formulations were similarly effective in improving lung function in patients with COPD.

Reviewed by Gary D. Vogin, MD

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