MDI achieves goals with Penthrox trial

Drug developer Medical Developments International (ASX:MVP) achieved all its objectives in a phase I safety study of its Penthrox methoxyflurane inhaler.

The study involved evaluating the effects of a single supratherapeutic dose of methoxyflurane, an analgesic, on healthy patients.

The study concluded that there are no safety concerns associated with a single above-therapeutic dose, no evidence of any effect of methoxyflurane on heart rate and no concerns uncovered in lab tests, including kidney- and liver-function tests.

Only two adverse events were deemed related to the administration of methoxyflurane - dizziness and mild headaches.

The randomised, single-centre, double-blind, double-dummy, placebo-and positive-controlled three-way crossover study was conducted at a single site in Australia. It involved 39 patients split into three patient groups.

The primary goal was to assess whether a supratherapeutic does of methoxyflurane increased the QT interval - the time between the onset and end of ventricular electrical activity.

Penthrox has long been available in Australia but Medical Developments International is working to introduce the product into new markets internationally, particularly Western Europe.

The study provides clinical evidence for regulatory submissions in other markets. The company plans to submit a Marketing Authorisation Application for some European countries by the end of September.

Medical Developments International shares were trading unchanged at $1.62 as of around 12 pm on Wednesday.