Patents Granted for Inhaled Rapid-Onset Aspirin Formulation

The US Patent and Trade Office (USPTO) has granted 2 new patents related to a novel inhaled rapid-onset aspirin formulation (Asprihale, OtiTopic) in development to treat suspected myocardial infarction (MI).

U.S. Patent No. 10,149,823, titled, “Dry powder formulations and methods of use,” and US Patent No. 10,195,147 titled, “Dry powder aspirin compositions with magnesium stearate,” protect the formulation in the United States through 2037. Technology related to the product is also protected by 3 previously granted utility patents, 2 issued by the USPTO and 1 issued by IP Australia and in Japan.

MI affects approximately 735,000 Americans annually, and are caused by blood clot, which results in an interruption of blood flow to the heart. If blood flow is not restored to the heart muscle immediately, the muscle tissue will begin an irreversible death. Most doctors recommend that anyone who thinks they are having a heart attack should take aspirin as soon as possible.

Considered to be the standard of care for at-risk patients in both the prophylactic and rescue setting, aspirin is prescribed to 90% of patients either in daily and/or rescue doses and prescribed in both forms for 45% of patients. Studies have shown improved mortality due to early administration of rescue aspirin upon the onset of MI.

OtiTopic’s inhaled aspirin is being developed to be administered at the time of a suspected acute MI as a rescue option. The portable dry powder is expected to deliver a proprietary aspirin formulation deep into the lung, where it can be absorbed into the bloodstream significantly faster than an oral tablet.

A preclinical study has demonstrated proof of concept for rapid absorption of the formulation. Researchers are expected to initiate a Phase 1 and Phase 2 dose range study in 2019.

References

OtiTopic Granted Two Patents Covering its Dry Powder Inhaled Aspirin for the Treatment of Suspected Myocardial Infraction [news release]. Published Feb. 27, 2019. https://www.businesswire.com/news/home/20190227005885/en. Accessed Feb. 28, 2019.