Intas Pharmaceuticals Gets CDSCO Panel Nod for Palatability Study of Temozolomide powder for oral suspension

New Delhi: The drug major Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the palatability study (acceptability, taste and smell, and oro-mucosal safety) for the anti-cancer drug Temozolomide in pediatric patients with malignant gliomas.

This came after Intas Pharmaceuticals presented their proposal for a grant of permission to conduct the palatability study (acceptability, taste & smell, and oro-mucosal safety) for Temozolomide powder for oral suspension at 20 mg/ml (300 mg/15 ml) in pediatric patients with malignant gliomas, along with the palatability study protocol, before the committee.

Malignant gliomas, the most common subtype of primary brain tumors, are aggressive, highly invasive, and neurologically destructive tumors considered to be among the deadliest of human cancers.

The firm informed that the proposed formulation is not yet approved in India or anywhere in the world.

The firm further added that they have already conducted a comparative bioavailability study for Temozolomide powder for oral suspension at 20 mg/ml (300 mg/15 ml) with TEMODAL (Temozolomide) capsules at 250 mg and found that they meet the bioequivalence criteria.

In addition, the firm also mentioned that they have applied only for the conduct of a palatability study in limited numbers of 14 Paediatric patients between 3 to <18 years old.

Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

Temozolomide is used to treat specific types of brain cancer (eg, glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed. It belongs to the group of medicines known as antineoplastics (cancer medicines).

At the recent SEC meeting for Oncology held on 18th June 2024, the expert panel reviewed the proposal for grant of permission to conduct of palatability study (acceptability, taste and smell, and oro-mucosal safety) for Temozolomide powder for oral suspension 20mg/ml (300 mg /15ml) in Paediatric patients with malignant gliomas along with palatability study protocol before the committee.

After detailed deliberation, the committee recommended conducting the palatability study for Temozolomide powder for oral suspension 20mg/ml (300 mg /15ml) as per protocol presented by the firm.

Furthermore, the expert panel added that one of the experts Dr. Sameer Bakshi (AIIMS, Delhi) does not participate in the deliberation due to a conflict of interest.

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