Justify Clinical Relevance of Higher Strength of Caroverine Capsules: CDSCO Panel Tells Lincoln Pharma
New Delhi: Noting that proposed higher strength of Caroverine Capsules (40mg) is not approved anywhere in the world, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined Lincoln Pharmaceuticals to submit therapeutic justification and clinical relevance of higher strength Caroverine Capsules 40mg along with Phase-III clinical trials protocol.
This came after Lincoln Pharmaceuticals presented the bioequivalence (BE) study report of Caroverine Capsules 40mg (additional strength) with a request for clinical trial (CT) waiver.
Caroverine belongs to the class 'antispasmodics', which is used for the treatment of smooth muscle spasms and tinnitus. It works by blocking the action of a chemical messenger in the brain (glutamate), thereby reducing the severity of tinnitus. It also acts as a smooth muscle relaxant with calcium-channel blocking properties used in conditions associated with painful smooth muscle spasms. CAROVERINE can be taken with or without food.
Caroverine is used in the treatment of tinnitus (ringing in the ears) and abdominal pain. Caroverine is an oto-neuroprotective (inner ear protective) medication. It works by blocking the action of a chemical messenger in the brain (glutamate) thereby reducing the severity of tinnitus.
At the recent SEC meeting for Neurology and Psychiatry held on 12th and 13th of December 2023, the expert panel reviewed the BE study report of Caroverine Capsules 40mg (additional strength) with a request for CT waiver.
After detailed deliberation, the committee observed that the proposed higher strength is not approved anywhere in the world.
In line with the above, the expert panel opined that the firm is required to submit a therapeutic justification and clinical relevance of higher strength Caroverine Capsules 40mg along with Phase-III clinical trials protocol for further review of the committee.
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