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The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has granted permission to Sun Pharma Ltd to conduct phase III clinical trial for its antipsychotic drug pimavanserin in India.
The permission was granted in a meeting held by the New Drug Division of SEC on January 18, in the CDSCO headquarters in New Delhi. The company submitted a revised phase III clinical trial protocol before the Committee following the latter’s recommendation in a meeting held on November 18, 2021. The application submitted by Sun Pharma is for pimavanserin capsules 34 mg.
“After detailed deliberation, the committee recommended grant of permission to conduct the phase III clinical trial,” said the minutes of the SEC meeting.
It may be noted that the company has earlier presented their proposal for BE waiver and Local Clinical Trial waiver along with justification for waiver and published data in support of safety and efficacy of the drug.
However, a meeting held on August 6, 2020, recommended that phase III clinical trial is required to be conducted and accordingly protocol should be submitted for review by the committee.
Pimavanserin, which is sold under the brand name Nuplazid, is an atypical antipsychotic drug for the treatment of complications related to Parkinson’s disease. Other Indian companies are also looking at exploring the market potential of the drug.
Zydus Cadila, in December, 2021, announced that it has received tentative approval from the US FDA to market pimavanserin tablets, 10 mg.
“Pimavanserin is used to treat the symptoms of a certain mental/mood disorder (psychosis) that might occur with Parkinson's disease. It helps lessen symptoms such as seeing or hearing things that are not there (hallucinations) and false beliefs (delusions),” said a company release.
Zydus said that the drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
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