Insignis Therapeutics Receives FDA Fast Track Designation for IN-001 for Anaphylaxis Treatment
13 Agosto 2024 - 6:30AM
Insignis Therapeutics, a pharmaceutical company focused on
developing innovative allergy and anaphylaxis treatments, is
pleased to announce that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for its investigational
drug, IN-001, a novel needle-free epinephrine delivery system
utilizing a sublingual spray in a disposable device.
The FDA’s Fast Track program is designed to expedite the product
review and facilitate the development of drugs that treat serious
conditions and address unmet medical needs. This designation for
IN-001 underscores the critical need for innovative solutions in
the management of severe allergic reactions and anaphylaxis and
offers hope for millions of patients worldwide who are at risk of
life-threatening allergic events seeking a more convenient and
durable alternative to needle-based epinephrine products.
IN-001 represents multiple significant advancements in the field
of anaphylaxis treatment. Unlike traditional epinephrine
auto-injectors, IN-001 utilizes an FDA-approved epinephrine prodrug
sprayed under the tongue, providing rapid and effective epinephrine
administration without the use of needles. This breakthrough
addresses common barriers associated with needle-based devices,
such as needle phobia and the risk of incorrect administration,
making emergency treatment more accessible, reliable and less
intimidating for patients.
In addition, unlike the epinephrine auto-injectors and
epinephrine nasal spray products, IN-001 sublingual spray is not
temperature sensitive and remains stable and usable under extreme
temperature conditions from -20℃/-4°F to 60℃/140°F. This makes
IN-001 the first rugged epinephrine product that can be carried and
used under any temperature conditions without risking potency loss
or product failures. This breakthrough addresses the issues of
temperature sensitivity, poor stability, and short shelf life
plaguing traditional epinephrine auto-injectors, reducing the need
for frequent replacements and providing significant long-term
financial benefits to patients and their families.
"We are thrilled to receive Fast Track designation from the FDA
for IN-001," said Mingbao Zhang, PhD, MBA, CEO of Insignis
Therapeutics. "This recognition validates the urgent need for a
needle-free epinephrine delivery system and brings us one step
closer to providing a safer, less temperature-sensitive, more
stable, and user-friendly option for patients at risk of
anaphylaxis. We look forward to working closely with the FDA to
accelerate the development and review process, ensuring that IN-001
can reach those in need as quickly as possible."
The Fast Track designation allows for more frequent interactions
with the FDA, eligibility for priority review, and the possibility
of accelerated approval, all of which can significantly shorten the
time to market for IN-001. Insignis Therapeutics is committed to
advancing the development of IN-001 through rigorous clinical
trials and regulatory milestones to demonstrate its safety and
efficacy.
For more information about Insignis Therapeutics, please visit
www.insignisrx.com.
About Anaphylaxis
Anaphylaxis is a severe, potentially life-threatening allergic
reaction that can occur rapidly, often within minutes of exposure
to an allergen. Common triggers include certain foods, insect
stings, medications, and latex. The condition is characterized by a
sudden release of chemicals in the body, leading to symptoms such
as swelling, hives, difficulty breathing, a drop in blood pressure,
and, in severe cases, loss of consciousness. Immediate medical
treatment is crucial, typically involving an injection of
epinephrine, which can reverse the symptoms. Individuals at risk of
anaphylaxis are often advised to carry an epinephrine auto-injector
and wear medical identification to alert others to their
condition.
About Insignis Therapeutics
Insignis Therapeutics is dedicated to developing cutting-edge
treatments for severe allergies and anaphylaxis. By leveraging
advanced technology and scientific expertise, Insignis aims to
improve the quality of life for patients worldwide through
innovative, effective, and accessible medical solutions.
Company Contact:
Mingbao Zhang, PhDCEO, Insignis
Therapeutics203-570-8879mzhang@insignisrx.com
This press release contains forward-looking statements that
involve risks and uncertainties. Actual results may differ
materially from those expressed or implied in these statements.