A stable, easily manufactured intranasal oxytocin formulation that contains only food grade preservatives

Unmet Need

Current formulations of oxytocin used for the treatment of neuropsychiatric disorders have several drawbacks. For example, many intravenous and intranasal formulations, like those approved in Europe, contain preservatives like chlorobutanol which is highly toxic to the liver and is a severe irritant to the eyes and skin. There is currently no commercially available pharmaceutical grade intranasal oxytocin available in the US or approved by the FDA. Further, current formulations often are unable to deliver reliable doses of oxytocin thereby necessitating multiple dosages or rendering the formulation less effective due to poor absorption of larger volumes of intranasal solution. Hence, there is a need for new and improved formulations that are safe, do not contain harmful or toxic preservatives, and are able to deliver sufficiently concentrated oxytocin solution to promote reliable absorption.

Technology

Duke inventors have developed an oxytocin formulation for intranasal delivery. This formulation uses food grade preservatives and eliminates the need for chlorobutanol. It also eliminates the use of another widely used preservative, methyl paraben, thus eliminating the requirement for heating to get the parabens into solution and the subsequent cooling to prevent oxytocin degradation. This formulation has demonstrated stability and has been administered to 3-17 year olds with ASD in Phase 2 clinical trials with no major safety signals identified.

Other Applications

This formulation could also benefit patients with Prader Willi syndrome, weight loss, schnizophrenia, anxiety disorders, migraines, and a range of other conditions that benefit from oxytocin administration.

Advantages

• Uses food grade preservatives rather than toxic preservatives like chlorobutanol
• Demonstrated to be safe in Phase 2 clinical trials
• A single therapeutic dose can be delivered in one dose rather than the six required for Syntocinon
• Has demonstrated exceptional long-term stability over the 19 months it was tested
• Can be manufactured in large batches more quickly by eliminating the heating and cooling steps associated with methyl paraben