Last Updated on October 11, 2024 by The Health Master
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted permission to drug-maker Torrent Pharmaceuticals to manufacture and market the Pregabalin plus Duloxetine capsule, which is used in the treatment of neuropathic pain.
The approval came after Torrent Pharmaceuticals presented the detailed safety data for the fixed-dose combination drug Pregabalin plus Duloxetine (75 mg + 20 mg, 50 mg + 20 mg & 75 mg + 30 mg), in light of an earlier SEC recommendation dated 17.08.2021.
Pregabalin is an anticonvulsant drug used to treat neuropathic pain conditions and fibromyalgia, and for the treatment of partial onset seizures in combination with other anticonvulsants.
The fixed-dose combination drug Pregabalin plus Duloxetine is available on the market under the brand names Pregabid-D, marketed by Intas Pharmaceuticals, and Pregamax-D, marketed by Winmark Pharmaceuticals.
Earlier, at the 69th SEC meeting for Neurology & Psychiatry, Torrent Pharmaceuticals presented their proposal along with a Phase III clinical trial report for a fixed dose combination of Pregabalin plus Duloxetine capsule before the committee.
Responding to this, the committee opined that the firm had shown that the FDC was not inferior to the reference product in terms of efficacy.
However, the committee noted that the safety data presented could not ascertain the safety due to a lack of statistical analysis of adverse events between both reference and test products, and after detailed deliberation, the committee recommended during the 69th SEC meeting that the firm should present the safety data again after due analysis for further consideration.
In continuation, the firm at the 73rd SEC meeting for Neurology & Psychiatry, dated 14.10.2021, presented their proposal along with the detailed safety data.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed FDC.
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