Australian pharmaceutical company LTR Pharma Limited (ASX: LTP) on Thursday introduced Roxus, a prescription nasal spray for erectile dysfunction (ED), to patients across the United States.
The product delivers vardenafil via the company's proprietary intranasal technology, using the same formulation as SPONTAN, its ED spray prescribed in Australia. Its nasal absorption is designed to avoid delays associated with heavy meals.
Clinical studies, including a peer-reviewed Phase 1 trial, showed the spray reached peak blood levels in a median of about 10 minutes, compared with 45–60 minutes for vardenafil delivered in tablet form. Men aged 65 and older achieved peak levels equally quickly, and the spray used one quarter of the tablet dose.
LTR Pharma has partnered with Shed to distribute Roxus through Mavrox, a US telemedicine platform for men's health. Patients complete an online assessment, which is reviewed by a licensed provider, and prescriptions are filled and shipped by Strive Pharmacy; in-person consultations remain an alternative route.
SPONTAN is progressing through the US FDA 505(b)(2) pathway toward a planned Phase III study.
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