Hetero Lab Gets CDSCO Panel Nod To Study Pregabalin, Polmacoxib FDC tablet
New Delhi: The drug major Hetero Labs has got approval from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct a bioequivalence (BE) study and Phase III clinical trial of fixed-dose combination (FDC) pregabalin extended released 82.5mg plus polmacoxib 2mg tablet for treating moderate acute, chronic or neuropathic pain.
However, this approval is subject to a condition that the firm should initiate the phase III clinical trial only after submitting the study results of the BE study.
This came after Hetero Labs presented its proposal along with BE study and Phase III clinical trial protocol before the committee.
Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.
Pregabalin capsules, oral solution (liquid), and extended-release (long-acting) tablets are used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes and postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles).
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