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Update: Oxytocin Phase 2 Trial

It has been nearly one year since we learned of the initial potential of oxytocin and PWSA (USA) began raising funds for the phase 2 clinical trial. This trial will provide us a greater understanding of the potential benefits, appropriate dosage needed, and additional vital information. The phase 1 study results were very positive and have been submitted for publication. We are amazed and gratified by the response of the PWS community for this project. Over $600,000 has been raised to date which is sufficient to begin the phase 2 study.

While the fundraising campaign has proceeded, significant work has been underway to prepare for the clinical trial. This includes designing the protocol which determines how many patients should be enrolled, the dosages, and the criteria that will be measured.

One important consideration is what form of oxytocin to use. Not all oxytocin is the same. Each form of the drug might be made with different ingredients, a different purity, and different concentrations. Also, it is extremely important that whichever brand is selected is well positioned to be quickly moved forward after this next trial. Otherwise, there might be a longer delay before the drug is on the market for PWS.

PWSA (USA) and everyone involved in this effort want to move as quickly as possible. We receive urgent calls almost every day from families that might benefit from oxytocin. But as stewards of the funds raised, we want to make sure it is invested to maximize the information learned from the trial and to speed future development. So please bear with us as we work to optimize the trial.

In the meantime, we continue to seek additional funds for the trial. While we could support the study with the funds raised to date, it would be beneficial to raise additional donations. That would allow the researchers to enroll more patients and do more testing which could provide more definitive information regarding oxytocin.

To donate, click here

We also want to pass along one note of caution. We are aware that oxytocin is available today through the internet or compound pharmacies. Despite the potential of oxytocin, we strongly encourage all families to resist trying any of these forms of oxytocin. Until oxytocin is properly studied in PWS, it could be dangerous or ineffective to give your loved one oxytocin. As the father of a daughter who has PWS and might benefit from oxytocin, I want this drug vetted and approved as much as anyone. Working in the pharmaceutical industry, I am well aware of the precautions we need to take in order to move this drug forward so it can eventually be available to all of our children.

Thank you,

Rob Lutz, co-chair of PWSA (USA) Research Committee

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