14 New Nasal Spray for Erectile Dysfunction Now Available in Australia and the USA Before the launch of sildenal (Viagra), treatments for erectile dysfunction (ED) were limited. Vacuum pump devices were an option, and for a short period a urethral suppository containing alprostadil was available (MUSE). Intracavernosal injections were the most effective treatment option available but were understandably not particularly appealing to the majority of most men who feared having to self-inject medication into the penis. The availability the rst oral medication to treat ED (a phosphodiesterase type 5 inhibitor - PDE5I) took the world by storm and millions of men benetted from a convenient and simple option to treat their ED. However, PDE5 inhibitors take a bit of time to work, which means that spontaneity sometimes has to take a back seat, and planning is required for sexual encounters. So it's not surprising that a fast-acting PDE5 inhibitor would be an appealing option for those “unplanned encounters.” A nasal formulation was developed containing the PDE5 inhibitor vardenal (an established oral treatment originally co-developed by Bayer, GlaxoSmithKline, and Schering-Plough and approved as an oral tablet (Levitra) in August 2003). A comparative study was published in the Journal of Sexual medicine in June 2023. The study showed that the nasal formulation reached peak concentration in 10 minutes vs 58 minutes for the oral formulation. That's a one third reduction in waiting time! Australian biotech rm LTR Pharma scaled up commercialization of the formulation under the development name SDS-089 (branded as Spontan® in Australia and Roxus® in the United States). Human bioequivalence clinical trials for this commercial product kicked off in February 2024, and it ofcially entered the U.S. consumer market via prescription in October 2026. The new formulation is available through a compound pharmacy and has not undergone FDA review or approval.
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