Roxus® ED Nasal Spray Now Available in the U.S.: Peak Blood Levels in About 10 Minutes, Not an Hour

(ASX:LTP) LTR Pharma Limited announced that Roxus®, a prescription nasal spray for erectile dysfunction (ED) delivering vardenafil, is now available to men across the U.S. Roxus uses LTR Pharma's proprietary intranasal spray technology and delivers the same type of ED medicine as Viagra®, but via the nose instead of orally. The intranasal vardenafil formulation in Roxus is the same as that used in SPONTAN®, LTR Pharma's nasal spray prescribed in Australia for the past two years. In clinical studies, including a peer-reviewed Phase 1 study, the spray reached peak blood levels in a median of about 10 minutes, compared to 45 to 60 minutes for vardenafil tablets. Men aged 65 and older reached peak levels just as quickly, and the spray achieved this with a quarter of the tablet dose. Roxus is designed to avoid delays caused by heavy meals, as it is absorbed through the nose rather than the stomach. Lee Rodne, Executive Chairman of LTR Pharma, stated that Roxus changes the experience for men and their partners by being effective within 5-10 minutes. Dr. Amy Pearlman, urologist and member of LTR Pharma's Scientific Advisory Board, commented that Roxus offers speed, discretion, and spontaneity in ED treatment. LTR Pharma has partnered with Shed, whose men's health telemedicine platform Mavrox brings Roxus to men nationwide. To obtain Roxus, men complete an online health assessment at Mavrox.com/Roxus, which is reviewed by a licensed U.S. provider, and if appropriate, Strive Pharmacy fills and ships the prescription. Roxus is also available through in-person healthcare providers. Roxus is a compounded medication prepared for individual patient needs based on a valid prescription and is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Common side effects include headache, flushing, runny or stuffy nose, indigestion, and temporary nasal discomfort. SPONTAN is progressing through the U.S. FDA 505(b)(2) pathway toward a planned Phase III study.