Torrent Pharma gets CDSCO panel nod to manufacture, market Pregabalin, Duloxetine FDC

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.

Although the exact mechanism of action is unknown, pregabalin selectively binds to alpha2delta (A2D) subunits of presynaptic voltage-dependent calcium channels (VDCCs) located in the central nervous system (CNS). Binding of pregabalin to VDCC A2D subunits prevents calcium influx and the subsequent calcium-dependent release of various neurotransmitters, including glutamate, norepinephrine, serotonin, dopamine, and substance P, from the presynaptic nerve terminals of hyperexcited neurons; synaptic transmission is inhibited and neuronal excitability is diminished.

Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications, including the treatment of neuropathic pain, generalised anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

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.