CDSCO Panel Rejects Akum Pharma's Clonazepam-Duloxetine Combination Drug

New Delhi: Reviewing the justification provided by the drug major Akum Pharmaceutical concerning the fixed-dose combination (FDC) Clonazepam plus Duloxetine Hydrochloride, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected approval for the proposed FDC.

This came after the drug maker Akum Pharmaceutical presented the proposal along with justification and rationality before the committee.

Clonazepam is a benzodiazepine drug used for the acute treatment of panic disorder, epilepsy, and nonconvulsive status epilepticus. The drug also has many off-label indications, including restless leg syndrome, acute mania, insomnia, and tardive dyskinesia.

Its primary mode of action is to facilitate GABAergic transmission in the brain by a direct effect on benzodiazepine receptors. GABA receptors lie on the cell bodies of dorsal raphe neurons, and GABA acts to inhibit raphe cell firing, an action potentiated by benzodiazepines.

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.

Duloxetine is used to treat major depressive disorder in adults. It is also used to treat general anxiety disorder in adults and children who are at least 7 years old. Duloxetine is also used in adults to treat nerve pain caused by diabetes (diabetic neuropathy), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

In line with the fixed-dose combination (FDC) Clonazepam plus Duloxetine Hydrochloride (Gastro-resistant pellets), at an earlier SEC meeting held on 12.10.2023, the expert panel suggested, 'The firm should present the justification on the rationality of the combination and its significant benefits'.

The expert panel also said that the proposed FDC was not approved anywhere in the world and that the firm should provide current, peer-reviewed scientific research to support the proposed indication of the FDC.

In continuation, at the recent SEC meeting for Neurology and Psychiatry held on 23rd February 2024, the expert panel reviewed the proposal along with justification and rationality of the FDC Clonazepam IP (as uncoated tablet) 0.5mg plus Duloxetine Hydrochloride IP eq. to Duloxetine (as Gastro-resistant pellets) 20mg capsule provided by Akum Pharmaceutical.

Following extensive consideration, the committee restated its previous recommendation that it not be approved by the FDC.

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