Dublin-based biopharmaceutical company Ovoca Bio is seeking Russian approval for a nasal spray that assists women suffering from a condition characterised by a “distressing lack or loss of sexual desire”.
The company, which has a focus on women’s health, informed the Irish stock exchange on Tuesday that a new marketing authorisation (MA) application for a novel synthetic peptide administered through a nasal spray was filed with the Russian Ministry of Health last week.
A subsidiary of the company filed the application for the treatment of hypoactive sexual desire disorder, a condition it described as “characterised by a distressing lack or loss of sexual desire in premenopausal women”.
The MA application is based on data from two Phase 1 studies, a Phase 2a study and the Phase 3 study conducted in Russia, which establish the safety and efficacy of the product.
A previous MA submission filed was not granted following the identification of issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier.
Ovoca said it was satisfied that the concerns raised have now been fully addressed. A new review process is expected to be a minimum of nine months duration.
Kirill Golovanov, chief executive of Ovoca Bio, said it was “a positive development” for the company.
“We are confident that the questions raised by the Minzdrav, related to the CMC and labelling portions of the previous application rather than drug safety or efficacy, have been addressed in this new submission,” he said.
“Outside of Russia we are continuing to progress our clinical development programme for BP-101 in high value Western markets.
“Preparations are advanced to start our Phase 2 dose ranging study in Australia and New Zealand, an important step towards ultimately establishing a clinical programme for BP-101 in the US and EU.”