According to Orexo, a Phase 1 trial of OX640 nasal epinephrine powder demonstrated that each of 4 formulations evaluated was safe and well tolerated and achieved epinephrine plasma levels comparable to autoinjected intramuscular epinephrine (EpiPen). Each of the intranasal formulations also produced concentration-dependent changes in blood pressure and heart rate. The OX640-001 trial, which enrolled 40 healthy volunteers, was initiated in July 2022.
OX640 epinephrine powder is based on Orexo’s amorphOX particle engineering technology, as are the company’s OX125 intranasal nalmefene and OX124 intranasal naloxone for the treatment of opioid overdose. Orexo says that it is seeking partners for OX640 and other amorphOX products for the treatment of conditions unrelated to mental health or substance use. The company recently received a European patent covering OX640 until 2041.
Orexo Senior VP and Head of R&D Robert Rönn commented, “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.”
President and CEO Nikolaj Sørensen 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.”
Read the Orexo press release.
