Synokem gets CDSCO Panel nod to manufacture and market FDC Nortriptyline,Gabapentin
New Delhi: Pharmaceutical major, Synokem Pharmaceuticals has got the go ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to manufacture and market the fixed dose combination (FDC) drug, Nortriptyline HCl eq to Nortriptyline 10mg/10mg plus Gabapentin 100mg/200mg which is used to relieve neuropathic pain.
However, the nod is subjected to condition that firm should conduct Phase IV Clinical Trial (CT).
This came after the firm presented their proposal before the committee along with bioequivalence (BE) study report as per the recommendations of the earlier committee meeting held on 16.04.2021.
Nortriptyline is a tricyclic antidepressant agent used for short-term treatment of various forms of depression. Nortriptyline blocks the norepinephrine presynaptic receptors, thereby blocking the reuptake of this neurotransmitter and raising the concentration in the synaptic cleft in the CNS. Nortriptyline also binds to alpha-adrenergic, histaminergic and cholinergic receptors. Long-term treatment with nortriptyline produces a downregulation of adrenergic receptors due to the increased stimulation of these receptors.
Gabapentin is an anticonvulsant medication used in the management of peripheral neuropathic pains, postherpetic neuralgia, and partial-onset seizures. Gabapentin inhibits the release of excitatory neurotransmitters, allowing for its use against pathologic neurotransmission such as that seen in neuropathic pain and seizure disorders.
At earlier meeting, in response to the firm's request for a Phase III CT waiver, the committee opined that the proposed lower strengths may be useful in the treatment of neuropathic pain and recommended for grant of permission conduct the proposed BE study. In addition, the expert panel also stated that the results of the BE study should be presented before the committee for considering the manufacturing and marketing approval.
In continuation, at the recent SEC meeting for Neurology & Psychiatry, the committee examined the proposal for FDC drug of Nortriptyline and Gabapentin presented by the drug-maker Synokem Pharmaceuticals along with bioequivalence (BE) study report.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the FDC with the condition that firm should conduct Phase IV CT.
In accordance with the above, the committee also directed that the firm should submit the protocol to CDSCO within 03 months from the date of approval of drug for review by the committee.
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