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.
Genezen agrees manufacturing collaboration with Galibra Neuroscience
Viking Therapeutics launches Phase 3 clinical programme for oral VK2735 in obesity
Coya Therapeutics plans open-label extension of COYA 302 ALS trial
Takeda reports positive Phase 2/3 results for investigational immunodeficiency therapy
Galderma to acquire ZO Skin Health for USD1.5bn to expand skincare portfolio
Orexo reports encouraging initial bioavailability results for oral semaglutide formulation
Pharming reports positive Phase II results for leniolisib in genetic immune disorders
Telix to present 20 abstracts on cancer theranostics at EANM Congress
CelLBxHealth secures USD65,000 pharmaceutical research contract
FDA grants Breakthrough Therapy Designation to Legacy Healthcare's CINAINU (LH-8)
Racura Oncology receives approval for RC220 trial to proceed to higher dose
Blue Lake Biotechnology reports interim data from Phase 1/2a paediatric clinical trial of BLB201
ArkBio reports FDA clearance of IND application for AK0406
Enodia Therapeutics partners with Pfizer on Sec61-targeting drug development
TWINBIRD launches portable freezer targeting dry-ice-free research cold chains