Suda Pharmaceuticals (ASX: SUD) is set to commercialise its SUD-001H migraine spray in the United States after securing an agreement with Strides Pharma Global.
Suda has developed a fast-acting oral spray that delivers sumatriptan to treat migraines. The spray is based on Suda’s proprietary OroMist hydrotrope technology.
According to Suda, once it collars US Food and Drug Administration approvals, its oral sumatriptan spray will be the first of its type commercially available in the US.
“There is a significant unmet medical need for a better treatment modality for patients with migraine headache, particularly patients that have rapid onset of pain and those with co-morbidity of severe nausea and vomiting,” Suda chairman and chief executive officer Stephen Carter said.
“For the these patients, SUD-001H offers an attractive treatment option with rapid absorption of the drug through the oral mucosa using our novel OroMist platform,” he added.
Under the development and commercialisation agreement with Strides, Strides will give Suda an up-front payment of US$400,000 (A$560,000) and a further payment of US$600,000 upon reaching various milestones including the first clinical study, and product submission and approval.
Strides will also fund product development services for SUD-001H and once commercialised, Suda will receive royalties and a handling fee.
Additionally, Strides will have the right of first refusal when looking to sell into other regions including the EU, Australian, New Zealand, Canada, South Africa and Japan.
Suda will work with Strides through the FDA approval process.
“Suda commissioned a primary marketing assessment of the US market to assess the potential for SUD-001H for the treatment of adult migraine,” Mr Carter explained.
“The market assessment confirmed the need for a product that could demonstrate a faster onset of action and a lower dosage.”
He added that the response from medical practitioners during the evaluation was “highly supportive”.
A migraine-type headache can last up to 72 hours, with patients frequently suffering nausea and vomiting as well as sensitivity to noise and light.
The National Headache Foundation estimates more than 36 million people in the US experience migraine headaches.
According to Suda, the US migraine treatment market was valued at US$1.2 billion in 2017.
Suda’s SUD-001H uses an oral spray formulation of GlaxoSmithKline’s sumatriptan drug, which is currently widely used to treat acute migraine in adults.
The company believes its oral mucosa delivery platforms has advantages over traditional administration forms including ease of use, faster response time, lower dosage and reduced side effects.
By mid-morning trade, Suda’s share price had shot up 60% to reach $0.008.