Dr Reddy's Told to Justify Patient Numbers in Vonoprazan Phase IV Trial, Revise Protocol

New Delhi: Noting that the sample size was "too small" for a Phase IV study of Vonoprazan Tablets 10 mg and 20 mg, the Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organisation (CDSCO) has opined that Dr. Reddy's Laboratories justify the proposed sample size and define the number of patients to be enrolled for each (10 mg and 20 mg) strength and submit a revised protocol within 15 days to CDSCO for further review by the committee.

This came after the drug major Dr. Reddy's Laboratories presented the Phase IV clinical trial protocol titled "A Phase-IV Study to Assess the Safety and Effectiveness of Vonoprazan 10/20mg in Adult Patients with Acid Peptic Disorders" (Protocol no. DRL/VONO/2025-01, Version no.: 0, Dated: 24-06-2025) before the committee.

Vonoprazan Tablets 10 mg and 20 mg were approved earlier for manufacturing and marketing under specified conditions and require a Phase IV study to further assess their post-market safety and effectiveness in adult patients with acid peptic disorders.

“In line with the condition of permission for manufacturing and marketing of Vonoprazan Tablets 10 mg/20 mg, the firm presented the Phase IV clinical trial protocol before the Committee,” the minutes stated.

Vonoprazan is a potassium-competitive acid blocker used in the treatment of acid-related disorders and as an adjunct to Helicobacter pylori eradication.

At the recent SEC meeting for gastroenterology and hepatology, the expert panel reviewed the Phase IV clinical trial protocol titled “A Phase-IV Study to Assess the Safety and Effectiveness of Vonoprazan 10/20mg in Adult Patients with Acid Peptic Disorders.” (Protocol no. DRL/VONO/2025-01, Version no.: 0, Dated: 24-06-2025), presented by Dr. Reddy’s Laboratories.

After detailed deliberation, the committee noted,

“The proposed sample size is too small considering that this is a Phase IV trial.

Also, there is no sample size specified for the higher (20 mg) dose, which is a more important target for this phase IV study.”

Accordingly, the committee opined,

“The firm should submit a justification for the proposed sample size and define the number of patients to be enrolled for each (10 mg and 20 mg) strength and submit a revised protocol within 15 days to CDSCO for further review by the committee.”