Synokem gets CDSCO panel nod to market FDC Nortriptyline, Pregabalin

This came after the firm presented the bioequivalence (BE) report and active post-marketing surveillance (PMS) study report before the committee at the 78th SEC meeting for Neurology & Psychiatry held on 10.03.2022.

At the same meeting, the drug major Synokem Pharmaceuticals has also got approval to manufacture and market a fixed-dose combination drug, Pregabalin IP (as prolonged release form) 75mg plus Nortriptyline Hydrochloride IP eq. to Nortriptyline 10mg plus Mecobalamin IP 1500mcg film-coated bilayered tablet.

The fixed dose combination drug containing Pregabalin plus Nortriptyline is used for neuropathic pain and to treat certain types of long-lasting pain caused by damage to nerves.

Pregabalin is structurally similar to gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia, among other conditions. Pregabalin is an alpha2-delta ligand that decreases pain by modulating the calcium channel activity of the nerve cells.

Nortriptyline hydrochloride, the active metabolite of amitriptyline, is a tricyclic antidepressant (TCA). It increases the levels of chemical messengers (serotonin and noradrenaline) that stop the movement of pain signals in the brain. It is used in the treatment of major depression and is also used off-label for chronic pain and other conditions.

Pregabalin plus Nortriptyline is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury, etc.

Few popular brands of Nortryptyline 10 mg plus pregabalin 75mg FDC drug marketed in India include Torrent Pharma's Norpregalin Tablet, Pregalin NT Tablet, Sun Pharma's Maxgalin NT Tablet, Lupin's Maxgalin NT Tablet and others.

At the recent SEC meeting for neurology and psychiatry held on March 10th, 2022, the committee extensively reviewed the BE report and Active PMS study report presented before the committee.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed FDC.