OtiTopic Moves towards Its Clinical Phase with Dry Powder Inhalation of Aspirin to Reduce the Risk of Vascular Mortality in Patients with Suspected Acute Myocardial Infarction (Ml)

New England Journal of Medicine Study Reports Harmful Side Effects of
Daily Aspirin

LOS ANGELES–(BUSINESS WIRE)–Extensive studies on the effects of Aspirin on human health have been
conducted over the past 100 years. Cardiovascular diseases are one of
the top causes of death in America among older adults. For the past
couple of decades, daily low dose aspirin has been a primary agent used
to manage and prevent cardiovascular disease. It was recommended that
patients (men over 50, women over 60) should take a low aspirin dose
daily to prevent heart attacks.

However, recently the New England Journal of Medicine published a
finalized study https://www.nejm.org/doi/full/10.1056/NEJMoa1805819
which shows daily low dose aspirin provides no significant health
benefits and may cause serious harm. The study conducted was a
randomized, double blind, placebo-controlled trial that recruited over
19,000 individuals with a median age of 74. Half of the population was
given aspirin and the other half received placebos. That study concluded
that “The use of low-dose aspirin as a primary prevention strategy in
older adults resulted in a significantly higher risk of major hemorrhage
and did not result in a significantly lower risk of cardiovascular
disease than placebo. (Funded by the National Institute on Aging and
others; ASPREE ClinicalTrials.gov number, NCT01038583.)”

Also, CNN reported on March 18, 2019: “Daily aspirin to prevent heart
attacks no longer recommended for older adults” https://www.cnn.com/2019/03/17/health/aspirin-heart-disease-guidelines/index.html.

With the side effects of daily dose aspirin outweighing the benefits,
OtiTopic is an industry leader in clinical trial stages innovating a new
method for emergency delivery of aspirin to patients at high risk of
Myocardial infarction (MI). OtiTopic will be conducting a clinical trial
to test whether aspirin delivered by inhalation could be more
advantageous in providing more rapid absorption and a quicker onset of
action than Aspirin delivered orally. As time is an important factor in
acute MI outcome (“Time is Muscle”), the desired route of administration
is one which has the potential to offer faster delivery to the
circulation. A method for efficient emergency delivery of Aspirin at the
onset of MI symptoms makes the chronic administration of low dose
aspirin unnecessary.

The combination of the Asprihale portable single-use device and patented
aspirin inhalation formula allows for faster absorption compared to the
oral administration of Aspirin. In the upcoming clinical trials, the
Pharmacodynamics (PD) and pharmacokinetics (PK) of oral inhalation of
aspirin will be tested. The results will be used to support a Phase II
clinical trial To Reduce the Risk of Vascular Mortality in Patients with
Suspected Acute Myocardial Infarction.

OtiTopic has finalized its toxicology study in animals and is now in the
clinical stages of product testing. Kambiz Yadidi, CEO and president of
OtiTopic, states, “With the findings on the side effects pertaining to
daily aspirin dosing, I think it is important to look at new ways to
innovate this product. This new method of delivery will allow patients
to receive the benefits of aspirin without the side effects. Patients
will benefit from having a rescue drug device that is easy to carry and
use at the time of MI symptoms. High-risk patients can rapidly inhale
Asprihale, and benefit from having quicker access to the drug. This new
product can save countless lives.”


OTITOPIC™ (http://otitopic.com/)
is an early stage pharmaceutical, privately funded drug development
company with a track record of success in Pharmaceutical product drug
delivery and drug device development. ASPRIHALE™ is a proprietary Dry
Powder Inhalation of aspirin formulation delivered via portable dry
powder inhaler (DPI) that is expected to enter the bloodstream faster
than oral tablets at the time of MI. OTITOPIC™ is on track with
ASPRIHALE™ to file an NDA for a novel drug-device combination product in
rescue management of suspected acute myocardial infarction (MI).
OTITOPIC™ is committed to providing high-risk MI patients with a faster
alternative for management of suspected myocardial infarction (MI).


Kambiz Yadidi
[email protected]

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