Epinephrine
Sublingual Film

Reimagining how to treat anaphylaxis

Anaphylm™* Epinephrine Sublingual Film is the first and only orally delivered film using Aquestive's novel prodrug of epinephrine in clinical development that has the same target indication as that for epinephrine injection in the emergency treatment of Type 1 allergic reactions, including anaphylaxis.

Aquestive recognizes the need for an oral formulation of epinephrine and is leveraging its proprietary PharmFilm^® technology to develop this treatment.

About Anaphylaxis

Anaphylaxis is a serious systemic hypersensitivity reaction with rapid onset and potentially fatal.

The most common causes of reactions that can include anaphylaxis are medications, foods (such as peanuts), and venom from insect stings. Epinephrine injection is the current standard of treatment intended to reverse the potentially severe manifestation of anaphylaxis, which may include red rash, throat swelling, respiratory problems, gastrointestinal distress, and loss of consciousness.

The Unmet Need
Epinephrine is the cornerstone of anaphylaxis management, yet it continues to be underutilized due to:

Availability

Hesitation

Miseducation

Delayed Administration

Availability

In a nationwide patient survey by Wood, 52% of patients who had previously experienced anaphylaxis had never received an epinephrine auto-injector prescriptionand 60% of respondents did not have an epinephrine auto-injector currently available

Hesitation

Patients and caregivers using epinephrine auto-injectors often experience fear, anxiety, and needle phobia

Miseducation

Lack of knowledge of how to administer epinephrine and use EAIs
Patients’ assumption that a prescription is not necessary

Delayed Administration

Late administration of epinephrine has been linked to greater risk of a biphasic reaction, a recurrence of anaphylaxis following treatment for the condition
Severe outcomes and fatalities have been correlated with delayed administration of epinephrine
The currently available treatments are EpiPen®, which takes an average time of 22 minutes to reach maximum concentration in the blood, and epi 0.3mg intramuscular injection, which takes an average of 45 minutes to reach maximum concentration in the blood*

Anaphylm™ has the potential to solve these issues. The product:

Is similar in size to a postage stamp
Weighs less than an ounce
Begins to dissolve on contact with no water or swallowing required for administration
Has thinner and smaller packaging than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight

Anaphylm™ would allow patients and their providers to:

Quickly deliver epinephrine to control emerging symptoms and prevent progression

Alleviate the fears associated with auto-injectors and self-injury including needle phobia

Prevent improper administration or suboptimal dosing, including associated adverse events such as injection site necrosis and/or infections

Reduce the likelihood of noncompliance or delayed dosing because the sublingual film is small, portable, and can be administered quickly and easily

"Speed matters in delivering systemic epinephrine during an anaphylaxis event. Any delay can result in severe bronchospasm, acute respiratory failure and/or cardiovascular collapse including less favorable outcomes including death."

Dr. David Bernstein, University of Cincinnati

"The PK profile of DESF shows an impressively rapid onset of action. The early Tmax and high Cmax fit the profile that is most desirable to stop anaphylaxis at an early stage and prevent progression to more severe reaction. The rapid achievement of high concentrations with DESF would seem ideal for early and effective treatment of anaphylaxis."

Dr. Golden , Sinai Hospital, Baltimore

For the latest on our clinical trials, visit

Clinical Trials

For information on our experienced Scientific Advisory Board members who share our goal of simplifying complex treatment conditions to improve the patient experience in allergy, visit:

Scientific Advisory Board

*Aquestive data on file

*Received conditional proprietary approval from FDA

1. Turner PJ, et al. World Allergy Org J. 2019;12100066. 2. Shaker, M, et al. Allergy Clinical Immunology J. 2021; Volume 145, Number 4. 3 https://www.aaaai.org/conditions-treatments/allergies/anaphylaxis. 4. Simons FE et al. World Allergy Organ J . 2015;8(1):32. 2. 5. Wood RA, et al. J Allergy Clin Immunol. 2014;133:461-467. 6. Chad L, et al. Eur J Allergy Clin Immunol. 2013;68:1605-1609. 7. Orenius T, et al. SAGE Open Nursing. 2018;4:1-8. doi:10.1177/2377960818759442. 8. Song TT, et al. Curr Opin Allergy Clin Immunol. 2015;15:323-328. doi:10.1097/ACI.0000000000000185. 9. Dudley LS, et al. West J Emerg Med. 2015;16(3):385-387. doi:10.5811/westjem.2015.25337. 10. Cardona V, et al. World Allergy Org J. 2020;13:13100472. 11. Mcleon & Rogers M. J Adv Nurs. 2019;75(1):30-42. 12. Cardona V, et al. World Allergy Org J. 2020;13:13100472. 13. Rachid et al., (2020): Pharmaceutics. 2018;10(1):24

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To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.
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Epinephrine Sublingual Film

Reimagining how to treat anaphylaxis

About Anaphylaxis

The Unmet Need Epinephrine is the cornerstone of anaphylaxis management, yet it continues to be underutilized due to:

Epinephrine is the cornerstone of anaphylaxis management, yet it continues to be underutilized due to:

Anaphylm™ has the potential to solve these issues. The product:

Is similar in size to a postage stamp

Weighs less than an ounce

Begins to dissolve on contact with no water or swallowing required for administration

Has thinner and smaller packaging than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight

Anaphylm™ would allow patients and their providers to:

Quickly deliver epinephrine to control emerging symptoms and prevent progression

Alleviate the fears associated with auto-injectors and self-injury including needle phobia

Prevent improper administration or suboptimal dosing, including associated adverse events such as injection site necrosis and/or infections

Reduce the likelihood of noncompliance or delayed dosing because the sublingual film is small, portable, and can be administered quickly and easily

*Aquestive data on file

*Received conditional proprietary approval from FDA

Please complete this form:

Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

Please complete the form to receive a demonstration kit for our PharmFilm® technology.

Please complete this form:

Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

Please complete the form below and click submit to receive a copy of “The Art of LGS Book.”

Please complete our short form to speak with a business development specialist.

Epinephrine
Sublingual Film

The Unmet Need
Epinephrine is the cornerstone of anaphylaxis management, yet it continues to be underutilized due to: