Akums Drugs and Pharma Gets CDSCO Panel Nod to study Aceclofenac plus Drotaverine Hydrochloride tablet

Aceclofenac, a phenylacetic acid derivative, is a non-steroidal, anti-inflammatory drug (NSAID). It shares structural similarities with another NSAID, diclofenac. The drug was designed to improve tolerance and bioavailability. It has anti-inflammatory, analgesic, and antipyretic properties. Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Drotaverine is a phosphodiesterase-4 inhibitor used to alleviate gastrointestinal and genitourinary smooth muscle spasms. Drotaverine is a selective inhibitor of phosphodiesterase 4 (PDE4), which is an enzyme responsible for the degradation of cyclic adenosine monophosphate (cAMP). Inhibition of PDE4 leads to elevated levels of cAMP, leading to smooth muscle relaxation.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the proposal presented by the drug major Akums Drugs and Pharmaceuticals along with the active post-marketing surveillance (PMS) study protocol before the committee.

After detailed deliberation, the committee recommended conducting the Active PMS study.

In addition, the expert panel suggested that the result of the study should be submitted to CDSCO for review by the committee.

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