Public Consultation on Switching Vonoprazan to OTC Status in Japan

The Japanese Ministry of Health, Labour and Welfare is seeking public opinions on the potential switch of Vonoprazan (marketed as Takecab) from prescription-only to over-the-counter (OTC) status.

Key Details:

• Use & Mechanism: Vonoprazan is a Potassium-Competitive Acid Blocker (P-CAB) used for heartburn, stomach pain, and reflux esophagitis. Unlike traditional PPIs, it does not require acid activation and remains stable in acidic environments.
• Efficacy & Approvals:
• Clinical trials confirm its non-inferiority to lansoprazole in treating GERD and H. pylori eradication.
• Approved in 10+ countries, including the U.S. and Asia, though the orally disintegrating tablet form remains unapproved overseas (as of December 2023).
• The Ministry invites public input on Vonoprazan’s potential OTC availability to expand patient access.

Region: East Asia
Source: https://savvy.praise-net.jp:8443/Analysis/