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).
Pregabalin capsules and oral solution are also used to relieve neuropathic pain that can occur after a spinal cord injury and to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness, tenderness, tiredness, and difficulty falling asleep or staying asleep).
Polymyxin B is indicated for the treatment of infections of the urinary tract, meninges, and bloodstream, caused by susceptible strains of Pseudomonas aeruginosa.
Polmacoxib binds to carbonic anhydrase I/II (CA) with high affinity which reduces the cardiovascular side effects. Inhibition of Cyclooxygenase-2 (COX-2) - COX-2 enzyme is responsible for the conversion of arachidonic acid into prostaglandins that are mainly involved in inflammation.
At the recent SEC meeting Neurology and Psychiatry held on 12th July 2023, the expert panel reviewed the proposal presented by Hetero Labs along with BE study and Phase III clinical trial protocol before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study and Phase III clinical trial.
In addition, the expert panel suggested that the result of BE study should be presented for review by SEC, before initiation of the Phase III clinical trial
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