Sun Pharma's proposal to amend CT protocol for pimavanserin gets CDSCO Panel nod
New Delhi: Approving Sun Pharma's proposal to amend the existing clinical trial protocol for the atypical antipsychotic Pimavanserin Capsules, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit the correct version of protocol no. ICR/21/012 version no. 3.0 dated 25.11.2022 to CDSCO.
However, this recommendation is subject to the condition that the firm should keep point no. 1 of the inclusion criteria of the previously approved protocol as it is, i.e., patients of either gender, aged ≥ 40 years, with a documented clinical diagnosis of idiopathic Parkinson's Disease (PD) (as per UK PD Society Brain Bank Clinical Diagnostic Criteria) of duration ≥5.5 years, and Hoehn & Yahr stage ≤3 of the previously approved protocol.
This recommendation came after the firm presented a proposal for protocol amendment of the existing protocol no. ICR/21/012 version no. 2.0 dated 27.12.2021 before the committee.
Earlier, the Medical Dialogues Team had reported that, last year in January, drug major Sun Pharma had got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a phase III clinical trial of the new antipsychotic drug Pimavanserin, indicated for the treatment of hallucinations and delusions caused by Parkinson's disease.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.