New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug maker Ajanta Pharma to conduct bioequivalence (BE) study of Tadalafil Oral Jelly 20 mg (Orange Flavour), indicated for the treatment of erectile dysfunction in adult men.

However, the approval is subject to condition that physician opinion should be taken before enrolment the subjects in the study.

This came after the firm presented its proposal of manufacture and marketing permission for Tadalafil Oral Jelly 20 mg (Orange Flavour), indicated for the treatment of erectile dysfunction in adult men, along with bioequivalence (BE) study protocol before the committee.

Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It is an inhibitor that produces several downstream effects with the most common therapeutic effect being smooth muscle relaxation.

During sexual arousal, non-adrenergic non-cholinergic (NANC) neurons release nitric oxide (NO). Nitric oxide stimulates guanylate cyclase which converts guanosine triphosphate to cyclic guanosine monophosphate (cGMP). cGMP activates the cGMP-dependent kinase (PKG) in a signal cascade which activates K+ channels leading to the inhibition of Ca2+ channels, inhibits platelet activation, and inhibits smooth muscle cell proliferation while inducing apoptosis. This signal cascade is attenuated by PDE5 which breaks the phosphodiester bond of cGMP, converting it to GMP. Inhibition of PDE5 by tadalafil increases signalling via the PKG cascade which supports penile smooth muscle relaxation during sexual arousal by decreasing Ca2+ entry into smooth muscle cells. This smooth muscle relaxation allows blood to fill the corpus cavernosum thereby producing an erection.

Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.

Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night).

At the recent SEC meeting for Reproductive & Urology held on December 23, 2022, the expert panel reviewed the proposal of manufacture and marketing permission for Tadalafil Oral Jelly 20 mg (Orange Flavour) for the indication as “It is indicated for the treatment of erectile dysfunction in adult men” along with BE protocol before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct BE study of Tadalafil Oral Jelly 20 mg (Orange Flavour) as per the protocol presented subject to the condition that the physician's opinion should be taken before enrolment of the subjects in the study.

Accordingly, the committee recommended that the firm should submit BE study report for further review by the committee and consideration of clinical trials of the applied drug product

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