The European Patent Office has issued a notice of allowance to the biopharmaceutical company SteadyMed for its enhanced infusion-site pain reduction technology called the PatchPump infusion system.
A notice of allowance is a document sent to a patent applicant indicating that a patent examiner has issued the requested patent.
SteadyMed’s PatchPump infusion system will be combined with treprostinil, a vasodilatory prostacyclin analogue. The company hopes to market this drug-device combination for the treatment of pulmonary arterial hypertension (PAH) under the name Trevyent. Treprostinil is the only PAH therapy approved by the U.S. Food and Drug Administration (FDA) for both intravenous and subcutaneous administration. However, Trevyent remains an investigational therapy and has not yet been approved. The methods by which treprostinil is delivered are complex and can cause pain for patients.
“Currently, infusion-site pain is a common patient complaint when certain therapeutic drugs are delivered subcutaneously,” Jonathan M.N. Rigby, president and CEO of SteadyMed, said in a press release. “The patent application relates to the delivery of a topical anesthetic, or other pain-reducing drug, via the underside of our PatchPump infusion system, at the same time a therapeutic drug is delivered subcutaneously. The aim of this approach is to effect a reduction in infusion-site pain caused by the therapeutic drug. This is another significant patent to add to our robust intellectual property portfolio.”
If approved by the FDA, SteadyMed will offer PAH patients Trevyent, which will allow patients access to a pre-filled, pre-programmed, single-use, disposable infusion system for treprostinil, instead of an orally delivered version.
The PatchPump has sensors to provide patients with feedback about whether the drug has been successfully delivered and when the dose has ended. Market research has shown that 90% of clinicians who treat PAH preferred Trevyent over existing treatment options, and 55% of respondents gave Trevyent the highest possible rating.
SteadyMed plans to commercialize Trevyent in the United States, Europe, Canada, and the Middle East once it has obtained regulatory approvals.
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