Abbott gets CDSCO nod to market FDC Lidocaine plus Diltiazem hydrochloride
New Delhi: Pharmaceutical major Abbott has got the go-head from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) to manufacture and market fixed-dose combination drug containing Lidocaine 2% plus Diltiazem hydrochloride 2% Gel.
This came in line with the Phase 3 clinical trial report presented by Abbott for fixed dose combination drug (FDC) Lidocaine 2% plus Diltiazem hydrochloride 2% Gel.
Lidocaine 2% plus Diltiazem hydrochloride 2% Gel is a local anesthetic and calcium channel blocker respectively for the treatment of anal fissure and relief of the symptoms associated with anal fissure.
This Lidocaine 2% w/w plus Diltiazem hydrochloride 2% w/w Gel relaxes the sphincter muscle, which alleviates pain and allows stool to pass more easily.
This medication also promotes blood flow, which allows the healing process to begin. The ointment reduces pressure within the anal canal pressure, which diminishes pain and spasm.
Diltiazem and lidocaine are important medications in the treatment of anal fissures. Diltiazem relaxes the anal sphincter to aid in the healing process. Lidocaine provides pain relief by numbing the skin.
Doctors avoid prescribing narcotic pain medications for anal fissures because narcotics can cause constipation, which could worsen anal fissures.
The permission to conduct phase 3 clinical trial with FDC of Lidocaine 2% plus Diltiazem hydrochloride 2% Gel was granted on 20th November 2020 by the expert panel under the provision of Drugs and Cosmetics Act and Rules.
At the 46th SEC for Gastroenterology & Hepatology, dated 16.03.2022, the expert panel reviewed the report of Phase 3 Clinical Trial of Lidocaine 2% plus Diltiazem hydrochloride 2% Gel for the treatment of anal fissure and relief of the symptoms associated with anal fissure.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the proposed FDC.
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