Exclude patients above 65 years of age: CDSCO Panel Tells Sun Pharma on Eluxadoline trial
New Delhi: Responding to the drug major Sun Pharma's proposal to manufacture and market Eluxadoline tablets 75 mg and 100 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the trial excluding the patient above 65 years of age.
Furthermore, the expert panel suggested that the clinical sites should be geographically distributed in the country.
This came after the drug major Sun Pharma presented the proposal for a grant of permission for manufacturing and marketing of the drug Eluxadoline tablets 75 mg and 100 mg along with phase III clinical trial protocol and bioequivalence (BE) study report before the committee.
Eluxadoline is a mixed mu-opioid receptor agonist used to treat irritable bowel syndrome with diarrhea. Eluxadoline is a mu-opioid receptor agonist, kappa opioid receptor agonist, and a delta opioid receptor antagonist. Eluxadoline is used for diarrhea-predominant irritable bowel syndrome (IBS) because it reduces intestinal contractility and normalizes stress-induced acceleration of upper GI transit. Antagonistic activity at the delta receptor minimizes the constipating effect usually seen by mu-opioid receptor agonists alone. Because of its limited systemic bioavailability, there may be fewer side effects associated with the use of eluxadoline in comparison with other therapies used to treat diarrhea-predominant IBS.
At the recent SEC meeting for Gastroenterology and Hepatology held on 26th October 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma to manufacture and market the drug Eluxadoline tablets 75 mg and 100 mg along with Phase III clinical trial protocol and BE study report.
After detailed deliberation, the committee recommended to conduct the trial subject to the following conditions:
1. Patients above 65 years of age should be excluded.
2. The clinical sites should be geographically distributed in the country.
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