Torrent Pharmaceutical gets CDSCO Panel nod to conduct bioequivalence study of Prucalopride oral solution
New Delhi: Responding to the proposal presented by Torrent Pharmaceutical to manufacture and market Prucalopride oral solution 0.2 mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to conduct the bioequivalence study (BE) of the proposed drug.
In addition, the committee recommended submitting referred literature/studies for added excipients (propylene glycol, glycerol, and sorbitol) regarding any synergistic/agonist effect to the prucalopride on the CNS.
The committee also recommended that the firm submit a BE study report to CDSCO and get evaluated by the committee for further consideration of a clinical trial waiver.
This came after Torrent Pharmaceutical presented their proposal for a grant of permission for the manufacturing and marketing of Prucalopride oral solution 0.2 mg/ml along with justification for a waiver of the Phase-III clinical trial and bioequivalence study protocol before the committee.
The firm informed that they are already holding marketing authorization (MA) permission for Prucalopride tablets 1mg and 2mg issued by CDSCO on 13.04.2017 for the same indication. However, the applied formulation Prucalopride oral solution 0.2 mg/ml is not yet approved anywhere in the world.
Prucalopride is in a class of medications called serotonin receptor agonists. Prucalopride is used to treat chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication).
Prucalopride is used to treat chronic idiopathic (unknown cause) constipation (CIC). It works by increasing peristalsis (contractions) in the colon, leading to an increase in the number of bowel movements.
At the recent SEC meeting for Gastroenterology and Hepatology, the expert panel reviewed the proposal for the grant of permission for the manufacture and marketing of Prucalopride oral solution 0.2 mg/ml along with justification for the waiver of the Phase-III clinical trial and bioequivalence study protocol.
After detailed deliberation, the committee recommended granting permission to conduct a BE study as per protocol (Protocol No.: PK-24-036, Version No.: 01 Date: 17.08.2024) presented by the firm.
Further, the committee opined that the firm should submit referred literature/studies for added excipients (propylene glycol, glycerol, sorbitol) regarding any synergistic/agonist effect to the prucalopride on the CNS.
In addition, the expert panel stated that the firm should submit a BE study report to CDSCO and get evaluated by the committee for further consideration of a clinical trial waiver.
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