Clinigen Group has secured marketing authorisations from the Medicines and Healthcare Products Regulatory Agency (MHRA) for Melatonin 1mg/ml oral solution and Melatonin 3mg film-coated tablets.
Both products are indicated for the short-term treatment of jet lag, a physiological condition in adults where rapid long-distance travel causes alterations to the body’s circadian rhythms.
The authorisation was obtained following the launch of Clinigen Group’s Glycopyrronium Bromide Oral Solution.
Clinigen group CEO Shaun Chilton said: “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.”
By supplying products on an unlicensed basis, the company will be able to identify where patient demand is high.
The company identified and evaluated both forms of Melatonin for technical and commercial feasibility to determine their suitability to add to the commercialisation pipeline.
Based on this assessment, Clinigen used its in-house product development capabilities, and regulatory / commercialisation expertise to submit a dossier to the MHRA that demonstrated the drugs safety, efficacy and quality.
In February this year, Novartis signed an agreement to divest the US rights to its Proleukin (aldesleukin) medicine to Clinigen for up to $210m.