WARREN, N.J., Jan. 13, 2025 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today provided an update on recent business developments and outlined key objectives for 2025.
“In 2024, we significantly advanced the Company and delivered on our key milestones. Our achievements last year have positioned the Company for continued success in 2025,” said Dan Barber, President and Chief Executive Officer of Aquestive. “We believe our long-term growth strategy remains compelling with the potential approval and launches of Anaphylm, Libervant (patients 6+), and AQST-108 in the U.S. and around the world. Our focus in 2025 is on 1) preparing for the potential approval and launch of Anaphylm for the treatment of severe allergies, including anaphylaxis, in the U.S. as early as the first quarter of 2026, 2) actively pursuing our ex-U.S. development strategy for Anaphylm, 3) successfully conducting our Phase 2a clinical trial in alopecia areata for AQST-108, 4) continuing to expand our sales of Libervant® (diazepam) Buccal Film for patients between two to five years of age, and (5) continuing to shift our current revenue base from legacy products to Libervant and other growth opportunities. This is truly an exciting time at Aquestive.”
Anaphylm™ (epinephrine) Sublingual Film
In 2024, Aquestive made significant progress with Anaphylm, its innovative epinephrine delivery system. The Company concluded a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), which provided clear guidance on the regulatory pathway to NDA submission for Anaphylm. Additionally, Aquestive initiated a Phase 1 pediatric trial of Anaphylm in children aged 7 to 17 years and ≥30 kg, further demonstrating its commitment to expanding access to this treatment across age groups.
Aquestive is on track to submit the NDA for Anaphylm in the first quarter of 2025, with the goal of addressing critical unmet needs in severe allergy management. The anticipated NDA submission marks a pivotal step toward bringing this innovative treatment to market, underscoring Aquestive’s commitment to providing to patients the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA.
AQST-108 (epinephrine) Topical Gel
Aquestive successfully completed a pre-Investigational New Drug meeting with the FDA in December 2024. The written response received from the FDA was supportive of continued development and Aquestive remains on track to begin its Phase 2a trial in patients with alopecia areata (AA) in the second quarter of 2025.
An estimated 6.7 million people in the United States have been affected by AA. Of those affected, 43% are considered severe. The existing therapies for alopecia areata are janus kinase (or JAK) inhibitors. These systemic treatments with known side effects come with a “black box” warning and are expensive for patients. Even with these limitations, the current estimated market opportunity for JAK inhibitors is over one billion U.S. dollars. In the first in human Phase 1 clinical trial, AQST-108 demonstrated no serious adverse events or topical adverse events. Since AQST-108 is topical and there is evidence that it acts at the application site, it may not have systemic side effects. As a result of these conditions, AQST-108, if approved by the FDA as a treatment for severe alopecia areata, has the potential to capture meaningful market share for the treatment of these patients.
Libervant® (diazepam) Buccal Film
Aquestive received FDA approval for Libervant in 2024, enabling access for the treatment of seizure clusters in pediatric patients with epilepsy between two to five years of age. This milestone ensures younger patients in this age group have access to this essential treatment. In December 2024, the Company received Orphan Drug Exclusivity for Libervant for patients between two to five years of age until April 2031.
Libervant is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients with epilepsy between two to five years of age.
About Anaphylm™ (epinephrine) Sublingual Film
Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller 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. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About AQST-108 (epinephrine) Topical Gel
AQST-108 is a topically delivered adrenergic agonist prodrug gel product candidate. Aquestive completed a first in human study for AQST-108 that measured the amount of epinephrine that remained on the skin or was found in circulation over time after the application of the gel and without any serious or topical adverse events. AQST-108 is based on Aquestive’s Adrenaverse™ platform that contains a library of over twenty epinephrine prodrug product candidates intended to control absorption and conversion rates across a variety of possible dosage forms and delivery sites.
About Libervant® (diazepam) Buccal Film
Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between two to five years of age. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including rectal gel and nasal spray products. The FDA granted tentative approval of Libervant in August 2022 for the treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The Company plans to submit an NDA and launch Libervant for these epilepsy patients between 6 to 11 years of age, if approved by the FDA, upon the expiration of the existing orphan drug market exclusivity scheduled to expire in January 2027. The FDA approval for U.S. market access received in April 2024 for Libervant is for these epilepsy patients between two to five years of age.
Important Safety Information Important Safety Information
Do not give Libervant® to your child if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma.
What is the most important information I should know about Libervant?
- Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
- shallow or slowed breathing,
- breathing stops (which may lead to the heart stopping),
- excessive sleepiness (sedation).
Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child.
- Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death.
- Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
- Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider.
- Give Libervant exactly as your child’s healthcare provider prescribed.
- Do not share Libervant with other people.
- Keep Libervant in a safe place and away from children.
- Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use.
- Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms.
- Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction.
- Do not give your child more Libervant than prescribed or give Libervant more often than prescribed.
Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills.
- Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child.
- Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse.
Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500.
- Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- new or worse depression
- feeling agitated or restless
- trouble sleeping (insomnia)
- acting aggressive, being angry or violent
- other unusual changes in behavior or mood
- attempts to commit suicide
- new or worse anxiety or irritability
- an extreme increase in activity and talking (mania)
- new or worse panic attacks
- acting on dangerous impulses
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your child’s healthcare provider as scheduled.
- Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes.
What are the possible side effects of Libervant?
- The most common side effects of Libervant are sleepiness and headache.
- These are not all the possible side effects of Libervant.
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use.
About Aquestive Therapeutics
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by the Company and its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for various dermatology conditions. For more information, visit Aquestive.com and follow us on LinkedIn.
