Precise Biopharma Gets CDSCO Nod To Market Hydrous Benzoyl Peroxide,Clindamycin Topical Gel
New Delhi: Precise Biopharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination of the Hydrous Benzoyl Peroxide plus Clindamycin Phosphate Topical Gel to treat acne.
However, this approval is subject to a condition that the firm must conduct the Phase IV clinical trial study in the approved patients 12 years of age and older with mild to moderate acne.
This came after Precise Biopharma presented its proposal before the committee along with toxicity data.
Benzoyl peroxide is a commonly used drug in topical treatments for acne. After administration, the peroxide bond is cleaved, allowing benzoyloxy radicals to nonspecifically interact with proteins. This treatment decreases keratin and sebum around follicles, as well as increases the turnover of epithelial cells.
Topical benzoyl peroxide exhibits bactericidal effects against Cutibacterium acnes, a key component of acne vulgaris. Benzoyl peroxide, once absorbed by the skin, is converted to benzoic acid. Approximately 5% of the benzoic acid is systemically absorbed and excreted by the renal system. The remaining benzoic acid is metabolized by cysteine in the skin, releasing active free-radical oxygen species resulting in the oxidization of bacterial proteins. Improvement of acne vulgaris occurs by reducing lipids, free fatty acids, and P. acnes.
Clindamycin is a lincosamide antibiotic used to treat serious infections caused by susceptible anaerobic, streptococcal, staphylococcal, and pneumococcal bacteria. Clindamycin inhibits bacterial protein synthesis by binding to 23S RNA of the 50S subunit of the bacterial ribosome.
At the recent SEC meeting for Dermatology and Allergy held on 26th July 2023, the expert panel reviewed the proposal presented by Precise Biopharma before the committee along with toxicity data.
The committee noted that the product is already approved in the United States.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product with the condition that the firm must conduct the Phase IV clinical trial study in the approved patients 12 years of age and older with mild to moderate acne.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol within 3 months from the date of approval.
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