LTR Pharma partners with Aptar to advance SPONTAN ED nasal spray in key global markets
LTR Pharma (ASX: LTP) and US-based Aptar Pharma have entered into a co-development agreement to commercialise LTR’s SPONTAN erectile dysfunction nasal spray in the US and other key markets.
The agreement will combine LTR’s pharmaceutical development capabilities with Aptar’s expertise in nasal spray technology to support a streamlined regulatory pathway and market access for the product.
It gives LTR access to Aptar’s comprehensive range of regulatory, analytical testing and human factors services to strengthen the application process for SPONTAN with the US Food and Drug Administration (FDA).
Long-term alliance
Aptar has previously supported numerous market authorisation holders in obtaining regulatory approvals for combination drug-device products which incorporate its nasal delivery systems.
LTR chair Lee Rodne said the companies would focus on imminent market establishment and expansion and form a long-term strategic alliance for ongoing innovations in healthcare solutions.
“We are delighted to enter into this agreement with a respected and experienced partner such as Aptar Pharma, with the goal of obtaining regulatory approval for SPONTAN and expanding our global market reach and impact,” he said.
“It vastly de-risks the FDA application process and elevates our profile as a long-term partner of a global market innovator, which we anticipate may create future opportunities for other products with alternative indications.”
Clinical trial results
In June, LTR Pharma published results from a clinical trial comparing the pharmacokinetics, safety and tolerability of vardenafil (Levitra) following administration of SPONTAN nasal spray and Levitra tablets in healthy male adults.
The trial showed that the first-in-kind nasal treatment achieved rapid absorption and faster onset of action compared to oral phosphodiesterase 5 (PDE5) inhibitors such as vardenafil and sildenafil, delivering a similar amount of drug at half the dose of an oral PDE5 tablet.
Results were achieved in as little as nine minutes with an average of 12 minutes across the study, compared to 56 minutes in patients receiving oral treatment.
Following positive results from the clinical trial, medical providers in Australia began prescribing SPONTAN under the Therapeutic Goods Administration Special Access Scheme.