Orexo Pharmaceuticals Announces Phase I Clinical Study Data

Months after announcing the development of a nasal epinephrine rescue medication, Orexo Pharmaceuticals announced positive phase I clinical trial data on the drug — called OX640. Epinephrine is a standard treatment for allergic reactions such as anaphylaxis. It is typically delivered via intramuscular injection, usually with an autoinjector.

According to the press release, the autoinjector market is currently valued at $2 billion and is expected to grow up to 9% each year. The study recruited 40 participants who tested four investigational formulations of OX640 and compared them to traditional autoinjectors. The study was a randomized, open-label trial conducted at a single location.

The study found that all the formulations were absorbed and achieved appropriate epinephrine levels in the plasma. The findings concluded that the impact of the formulations on heart rate and blood pressure was dependent on the concentration of the drug.

Robert Rönn, SVP and Head of R&D at Orexo, said, “the study results are truly exciting, and I am looking forward to the continued development of this important and differentiated product. The data also provides further validation of our drug delivery platform amorphOX and solidifies Orexo as a leader in advancing drug delivery with amorphous formulations and nasal delivery,” in the press release.

amorphOX is a proprietary drug delivery platform developed by Orexo. This technology presents the medication as an amorphous composite of the ingredients. It is thought that this platform can improve the chemical and physical stability of the drugs and allow for improved dissolution.

In the press release, Nikolaj Sørensen, President, and CEO of Orexo said, "Led by the development of OX124, our rescue medication for opioid overdose, we have continued to develop the amorphOX platform, and we are testing it in a wide range of both small and large molecules. With the positive results from the OX640 study, we once again show proof of concept of the excellent bioavailability provided by this scalable platform. The strong clinical and stability data, the global market need, and Orexo's ability to shorten the time to market through our established supply chain make this product attractive for partners all over the world.”

As clinical trials progress, healthcare facilities and providers should monitor the outcomes and approvals of the medication. If this product proves to have improved stability and efficacy, it may provide an additional tool for treatment that surpasses the current injection methods, as it will have fewer restrictions for storage.