A New Era in Myocardial Infarction Management
In 2019, OtiTopic completed a dose range study. Asprihale® reaches peak plasma concentration in two minutes versus 20 minutes for 162 mg non-enteric coated chewable aspirin. This rapid exposure is unprecedented and has enormous implications for early disruption of an evolving thrombus, where differences in time of restoration of blood flow within minutes with different therapies can be life-altering. The very high levels of serum thromboxane B2 (TxB2 ) suppression, and complete inhibition of arachidonic acid (AA)-induced platelet aggregation, both within two minutes, are unprecedented for a non-parenterally administered antiplatelet therapy.
Asprihale® aspirin exposure occurred more rapidly compared to chewed aspirin
With respect to Asprihale® PK, there is a 1.6-fold greater Cmax of aspirin when inhaled, which is similar to IV administration
Asprihale® early and consistent reduction in TxB2 led to early and consistent suppression of platelet aggregation by AA in two minutes
The immediate antiplatelet and inhibitory effects of Asprihale® would be expected to translate to meaningful clinical benefits in the early evolution of arterial thrombosis
Decreased interpatient variability of TxB2 inhibition and AA-induced platelet aggregation when aspirin is administered by the inhaled route of administration
The individual data for both AA-induced platelet aggregation and TxB2 inhibition show more rapid and consistent response in two minutes than chewable aspirin
OtiTopic's proprietary formulation contains particles engineered to produce an aerodynamic profile that results in maximum deep lung delivery. The aerodynamic profile is a result of the interaction between the inhaler and the formulation’s properties such as particle size and density. OtiTopic has evaluated countless formulations and devices to ensure that patients will receive an optimal therapy for management of suspected acute MI.
The current formulation has undergone design of experiment studies to prepare for validation of the commercial manufacturing process. Most analytical methods have passed Phase III validation to support sale and marketing of Asprihale® in the US. OtiTopic has been issued multiple patents and is the only company that can market orally inhaled dry powder aspirin worldwide.
The interaction between our capsule-based DPI and proprietary formulation creates an ideal aerodynamic profile that allows for deep lung delivery of the active ingredient. Asprihale® is easy to use and is delivered into the bloodstream in less than two minutes.Learn more
Asprihale® is a 505(b)(2) project. FDA has agreed that an accelerated clinical plan would be sufficient to bring the drug to market. OtiTopic has completed a dose range study and is preparing for a randomized pivotal PK/PD study to establish bioequivalence.
Clinical data indicates A 1.5 fold greater maximum serum concentration (Cmax) of acetylsalicylic acid (ASA) is achieved within 2 minutes.
When delivered with ASPRIHALE Arachidonic acid induced platelet aggregation is completely and irreversibly inhibited with ASPRIHALE within ~2 minutes post dose, and maintained for 24 hours post treatment.
Asprihale® completely inhibits AA-induced platelet aggregation within two minutes versus 30 minutes for chewable aspirin.
Inhibition of TxB2 in the first 20 minutes was greater in the Asprihale® group.
Mean serum thromboxane B2 (TxB2) levels are dramatically reduced over the first ~2 minutes post dose with ASPRIHALE, and maintained for 24 hours post treatment
The immediate anti platelet and inhibitory effects of ASPRIHALE is expected to translate to meaningful clinical benefits for patients at risk for MI