The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licensing of two Melatonin products indicated forshort-term jet-lag treatment in adults.
The marketing authorisations are for Melatonin 1mg/ml oral solution and Melatonin 3mg film-coated tablets, which are both indicated for the short-term treatment of jet-lag in adults.
The approval by the governing body means that the medicines can now satisfy a previously unmet clinical need for patients, in an area where where patient demand is high.
Overall the Group expect the products to be a modest contributor of growth within Clinigen’s Commercial Medicines business in the FY20E period, offsetting an expected decline from its supply as an unlicensed product from within its Unlicensed Medicines business.
Shaun Chilton, group chief executive officer, Clinigen, commented: “Obtaining MHRA approval for Melatonin has been driven by our dedicated team, which has shown a real determination to address this unmet medical need in the UK. This approval will ensure healthcare professionals can manage adult patients experiencing jet-lag with a licensed product, where before there was none.
“Identifying and developing products to offer licensed options to prescribers and patients is an important part of our strategy in Commercial Medicines. We are continuing to explore and invest to further strengthen and diversify the portfolio.”
Melatonin is a hormone secreted by the pineal gland that regulates the sleep/wake cycle. It regulates a variety of physiological processes, including circadian, cardiovascular, reproductive, and neuroendocrine functions. Administration of melatonin facilitates sleep onset and improves the quality of sleep.
Administration of melatonin can also produce phase shifts in circadian rhythms and has been used to treat the symptoms of circadian disorders.