CDSCO panel rejects Synokem's proposal to study Naftifine plus Beclomethasone Cream
New Delhi: Citing that the proposed fixed-dose combination (FDC) is not approved anywhere in the world, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the proposal presented by Synokem Pharmaceutical to study the fixed-dose combination (FDC) of Naftifine Hydrochloride plus Beclomethasone Dipropionate Cream.
This came after the firm presented the proposal before the committee along with the Phase III clinical trial study protocol of Naftifine Hydrochloride USP 2%w/w plus Beclomethasone Dipropionate IP 0.025 %w/w cream.
Naftifine topical is used to treat infections caused by a fungus or yeast. It works by killing the fungus or preventing its growth. Naftifine is used to treat the athlete's foot (interdigital tinea pedis; ringworm of the foot affecting the spaces between the toes).
Naftifine has a triple action: antifungal, antibacterial, and anti-inflammatory. Its fungistatic activity is believed to be based on inhibition of the squalene-2,3-epoxidase enzyme, which in turn results in the shortage of ergosterol required for the formation of fungal cell membranes.
Beclomethasone dipropionate is a second-generation synthetic corticosteroid and diester of beclomethasone, which is structurally similar to dexamethasone.
Beclomethasone Dipropionate to treat a variety of skin conditions (such as psoriasis, eczema, dermatitis, allergies, and rash). Beclomethasone reduces the swelling, itching, and redness that can occur in these types of conditions. It can also help to heal the rough, scaly skin patches seen with psoriasis.
Beclomethasone dipropionate works by attenuating the inflammatory responses associated with asthma, allergic rhinitis, nasal polyps, and corticosteroid-responsive dermatoses. It suppresses the actions of inflammatory cells, such as mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils.
At the recent SEC meeting for dermatology and allergy held on 12th October 2023, the expert panel reviewed the proposal along with the Phase III clinical trial study protocol of the FDC Naftifine Hydrochloride plus Beclomethasone Dipropionate Cream presented by the drug major Synokem Pharmaceutical.
The committee noted that:
1. The proposed FDC is not approved anywhere in the world.
2. The firm did not present any published literature in support of the significant clinical need for the proposed strengths of the FDC.
3. The dosing frequency of the proposed strengths of the FDC does not match.
4. Patients may also be unnecessarily exposed to the adverse effects of steroids.
5. There is no rationality for the FDC.
After detailed deliberation, the committee did not recommend approval of the FDC of Naftifine Hydrochloride plus Beclomethasone Dipropionate Cream.
