CDSCO Panel rejects Synokem proposal for FDC of Mecobalamin, Nortriptyline, Pregabalin

This came in line with the proposal presented by the drug major Synokem Pharmaceutical along with bioequivalence (BE) and Phase III clinical trial (CT) waiver before the committee.

The expert panel noted that the firm has not presented any scientific justification for the proposed strength. Furthermore, the committee stated that the firm has not presented any published scientific literature or peer-reviewed journal regarding essentiality and desirability in lower strength.

Mecobalamin IP 1500mcg plus Nortriptyline Hydrochloride IP Eq. to Nortriptyline 10mg plus Pregabalin IP 50mg film-coated tablet is a combination of three medicines which are Gabapentin, Nortriptyline (Antidepression), and Methylcobalamin (Vitamin Supplement). This medicine helps to treat nerve pain(Neuropathic pain). It is also useful in the regeneration of damaged nerves in the body.

It is also indicated to manage neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Neuropathic pain is a chronic progressive nerve disease that causes nerve pain due to nerve damage or a malfunctioning nervous system.

Methylcobalamin (MeCbl), the activated form of vitamin B12, has been used to treat some nutritional diseases and other diseases in the clinic, such as Alzheimer's disease and rheumatoid arthritis. Mecobalamin promotes functional and morphological recovery after peripheral nerve injury. The molecular mechanism underlying the restorative effects of mecobalamin on injured nerves may involve the upregulation of the genes for multiple neurotrophic factors.

Nortriptyline is from a group of antidepressants called tricyclic antidepressants. Nortriptyline inhibits the reuptake of serotonin and norepinephrine by the presynaptic neuronal membrane, thereby increasing the concentration of those neurotransmitters in the synapse. Additionally, nortriptyline inhibits the activity of histamine, 5-hydroxytryptamine, and acetylcholine.

Pregabalin reduces the synaptic release of several neurotransmitters, apparently by binding to alpha2-delta subunits, and possibly accounting for its actions in vivo to reduce neuronal excitability and seizures.

At the recent SEC meeting for neurology and psychiatry held on 18th and 19th January 2024, the expert panel reviewed the proposal presented by the drug major Synokem Pharmaceutical along with Phase III CT waiver of the FDC Mecobalamin plus Nortriptyline Hydrochloride plus Pregabalin Film Coated Tablets.

After detailed deliberation, the committee opined that:

1. The firm has not presented any scientific justification for the proposed strength.

2. The firm has not presented any published scientific literature or peer-reviewed journal regarding essentiality and desirability in lower strength.

3. The FDC is not rational in the proposed strength.

In view of the above, the committee did not recommend the approval of the proposed FDC.

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