Dr. Reddy's Gets CDSCO Panel Nod to Study FDC Etoricoxib plus Thiocolchicoside for Export purpose
New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to carry out the bioequivalence (BE) study of the fixed-dose combination drug Etoricoxib plus Thiocolchicoside capsule for export purpose.
However, this approval came in line with the condition of including Serum NT-pro BNP (Natriuretic Peptide Tests) to rule out the inclusion of subjects with chronic heart failure/ left ventricular systolic dysfunction.
This came after Dr Reddy's Laboratories presented its proposal along with the protocol of the BE study for export purposes.
Etoricoxib belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
Etoricoxib is a COX-2 selective inhibitor (approximately 106 times more selective for COX-2 inhibition over COX-1). Etoricoxib selectively inhibits isoform 2 of cyclo-oxygenase enzyme (COX-2), preventing the production of prostaglandins (PGs) from arachidonic acid.
Thiocolchicoside is a semi-synthetic derivative of colchicine, a natural anti-inflammatory glycoside that originates from the flower seeds of Superba gloriosa. It is a muscle relaxant with anti-inflammatory and analgesic effects.
Thiocolchicoside is a medication used to treat muscle spasms. Acting as an anti-inflammatory and analgesic drug, it reduces swelling in the body and relieves muscle stiffness while lowering pain and improving movement.
At the recent SEC meeting for analgesic and rheumatology held on 8th and 9th November 2023, the expert panel reviewed the proposal presented by the drug major Dr. Reddy's Laboratories along with the protocol of the BE Study of the FDC Etoricoxib plus Thiocolchicoside for export purpose.
After detailed deliberation, the committee recommended the grant of permission to carry out the BE study (for Export purpose, only) with the condition to include Serum NT-pro BNP to rule out the inclusion of subjects with chronic heart failure/ left ventricular systolic dysfunction.
