Swedish biopharmaceutical firm Medivir has today submitted a New Drug Application, its first, to US regulators for Lipsovir, its topical cold sore treatment.

Lipsovir is a combination of the anti-inflammatory hydrocortisone and the antiviral aciclovir. The filing is based on a Phase III programme which demonstrated that the development of cold sores can be prevented with early treatment initiation, “an effect that available products for this indication lack”.

The data showed that 42% of subjects treated with Lipsovir did not develop cold sores with blisters, ulcers and crusting, compared to 26% in the placebo group. The treatment also reduced the healing time of cold sores by 1.5 days as compared to placebo and was well-tolerated in all studied populations, including adolescents.

Head of development Borje Darpo said that the Stockholm-based company had a pre-NDA meeting with the US Food and Drug Administration in May, at which the Phase III results were presented and discussed. “We have since then worked hard to finalise all documentation,” he said, and the NDA “has been submitted in accordance with our previously-communicated time schedule”.

Chief executive Lars Andersson said that "it is a huge step forward for Medivir to file our first registration application”. He added that “the partnership process continues”, and the firm plans to work with “one or several companies to help us commercialise the product globally”.