UPDATED: Evidence that inhaled oxytocin improves social behavior among autistic patients spurs R&D

Additional evidence that oxytocin increases eye contact among autistic patients adds urgency to the efforts of GlaxoSmithKline ($GSK), OptiNose and other companies scrambling to develop an inhaled version of the "love hormone," which is naturally released during sex and breastfeeding.

Men with autism or Asperger syndrome made more eye contact with a female researcher when an oxytocin spray was dispensed prior to their video chat than they did in another interview in which they inhaled placebo spray. All 66 participants were exposed to both versions of the spray.

The eye-tracking software found that among the 32 men with autism or Asperger syndrome, eye contact with the interviewer rose from 0.59 times per second to 0.7 times per second. The group of men without autism experienced an increase in eye contact from 0.83 times per second to 0.9 times per second, says the paper in Translational Psychiatry.

The spray used was the nasal aerosol Syntocinon. It was developed by Novartis ($NVS) to help mothers eject milk during breastfeeding but withdrawn in 1997. Due to the plethora of studies showing oxytocin's beneficial effects on psychiatric disorders, Novartis licensed the spray to Retrophin for $5 million in 2013.

Retrophin says the spray is in Phase III trials for lactation and Phase II for schizophrenia and autism. Meanwhile, OptiNose has completed the Phase I study of its nasally inhaled oxytocin candidate for autism. OptiNose says the love hormone has poor oral bioavailability and that when delivered to the brain using standard liquid nasal spray only 3% of the oxytocin is circulated throughout the body. Furthermore, less than 0.01% of oxytocin in the blood crosses the blood-brain barrier, according to the website.

OptiNose COO Dr. Ramy Mahmoud said in an email to FierceDrugDelivery that nasal delivery is key because of so-called nose to brain effects. 

"The deepest crevices of the nasal cavity--high up under the eyes and under the front part of the brain--are the only place where the brain touches the outside world, but an important development challenge is that most nasal delivery (like nasal sprays) does not effectively reach that region. Nasal spray formulation that drips out or that gets swallowed doesn't do what is intended, so properly targeted delivery is one of the most important and unique challenges of this kind of program. Typical questions, like finding the correct dose and knowing how to best measure response to treatment, are also challenges that must be overcome," he explained.

Inhaled oxytocin could have other uses as well. Last year GlaxoSmithKline licensed technology from the Monash Institute of Pharmaceutical Sciences to develop an inhaled version of the love hormone for excessive bleeding following birth. The candidate is in Phase II.

Although it was discontinued by Novartis, Syntocinon is available via generic pharma company United Pharmacies.

- read the entire study or view the abstract

Editor's Note: This article was updated with additional information from OptiNose COO Dr. Ramy Mahmoud.

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