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LTR Pharma Introduces Roxus Nasal Spray for ED Treatment

Healthcare

Business Honor
26 March, 2025

LTR Pharma is improving ED treatment with Roxus, a nasal spray-mist medication aimed at early U.S. sales before FDA approval.

Australian drug maker LTR Pharma is breaking new barriers in the healthcare industry with its new nasal spray-mist erectile dysfunction (ED) medication. LTR Pharma recently introduced Roxus, a new product to gain early sales in the U.S. before eventually being approved by the U.S. Food and Drug Administration (FDA). Roxus, similar to LTR's initial drug Spontan, uses vardenafil, the same active ingredient used in such popular ED drugs as Levitra and Staxyn.

Roxus has a new model of early patient access via the 503(a)-compounding pharmacy pathway, exempting some drugs from the normal approval, labeling, and manufacturing requirements. This expedited route enables LTR Pharma to offer individualized therapy to ED patients, providing an answer while Spontan navigates the formal FDA approval channel. The company intends to launch Roxus in the U.S. during the first half of 2026, in partnership with an Australian drug firm.

LTR Pharma has also interacted with the FDA to be approved in proceeding with an abbreviated clinical development plan. They will carry out one pivotal trial of safety and efficacy and one multi-dose pharmacokinetic study, subject to explicit parameters for the process of approval.

Locally, Spontan has already caused a stir, with more and more prescribers coming to see its value as a differentiated ED treatment. Spontan can be accessed in Australia via the Special Access Scheme and the Authorised Prescriber Scheme. The product's rapid absorption rate—470% faster than standard ED tablets—has been a big selling point, with action-ready men achieving it as quickly as five minutes.

With 330 million men globally afflicted with ED, of which 30 million are in the U.S., LTR Pharma's innovations in the ED treatment arena have tremendous potential for solving a global health issue.