Aquestive Therapeutics, Inc. (AQST)
Aquestive Therapeutics, Inc. is a pharmaceutical company focused on discovering, developing, and commercializing products to address significant unmet medical needs across both the United States and international markets. The company's commercialized portfolio includes: Sympazan, an oral soluble film formulation of clobazam for individuals with Lennox-Gastaut syndrome. Suboxone, a sublingual film containing buprenorphine and naloxone, indicated for the treatment of opioid dependence. Zuplenz, an oral soluble film of ondansetron, used to manage nausea and vomiting associated with chemotherapy and post-operative recovery. Azstarys, a once-daily medication for attention deficit hyperactivity disorder. Aquestive maintains a robust proprietary pipeline of drug candidates. These include: Libervant, a buccal soluble film formulation of diazepam currently in development for the treatment of seizures. Exservan, an oral soluble film of riluzole, aimed at treating amyotrophic lateral sclerosis (ALS). Within its complex molecule pipeline, the company is advancing: AQST-108, a sublingual film designed to deliver systemic epinephrine for conditions other than anaphylaxis. AQST-305, a sublingual film formulation of octreotide for managing acromegaly. AQST-109, an orally administered epinephrine product candidate intended for the emergency treatment of severe allergic reactions, including anaphylaxis. Furthermore, Aquestive Therapeutics played a role in the development of KYNMOBI, a sublingual film formulation of apomorphine, used to address episodic "off" periods in patients with Parkinson's disease. Established in 2004, Aquestive Therapeutics, Inc. is headquartered in Warren, New Jersey.
Sector: Pharmaceutical Preparations
Industry: Drug Manufacturers - Specialty & Generic
Aquestive Therapeutics, Inc.
- Type I allergic reactions, including anaphylaxisCash runway at this date: 13mo
- seizure clusters in patients with epilepsy ages 6 to 11 (label expansion)Cash runway at this date: 13mo
- LIBERVANTPDUFAexpansion of label to add ages 6 to 11 for acute treatment of seizure clusters in epilepsyCash runway at this date: 13mo
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category
Epilepsy
NCT03428360Enrollment149StartJan 2018Primary CompletionJun 2020CompletionJun 2020 - Phase 2Completed
Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
Diazepam Buccal Film 12.5 mg
Epilepsy
NCT03179891Enrollment35StartMay 2017Primary CompletionJul 2018CompletionDec 2018 - Phase 2Completed
Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
Diazepam Buccal Film
Epilepsy
NCT03222349Enrollment24StartAug 2017Primary CompletionJan 2020CompletionMar 2020 - Phase 2Withdrawn
Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
Riluzole Oral Soluble Film
ALS
NCT03457753Enrollment0StartMar 2018Primary CompletionMar 2018CompletionMar 2018 - Phase 2Terminated
Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)
Riluzole Oral Soluble film (ROSF) 50 mg
Amyotrophic Lateral Sclerosis
NCT03679975Enrollment9StartApr 2018Primary CompletionSep 2018CompletionDec 2018 - Phase 2Completed
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome
DESF, Epinephrine Injection
Allergic Reaction
NCT06527937Enrollment36StartJul 2024Primary CompletionOct 2024CompletionOct 2024 - Phase 1/2Completed
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
Ondansetron (ODFS), Zofran (ODT)
Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced
NCT01217190Enrollment48StartSep 2008Primary CompletionSep 2008CompletionOct 2008 - Phase 1/2Completed
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
Diazepam Buccal Film, Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
Epilepsy
NCT03953820Enrollment31StartApr 2019Primary CompletionJul 2019CompletionJul 2019 - Phase 1Completed
Two Way Bioequivalence Study Under Fed Conditions
Ondansetron (ODFS), Ondansetron (ODT)
Healthy
NCT01217801Enrollment48StartOct 2008Primary CompletionOct 2008CompletionOct 2008 - Phase 1Completed
Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water
Healthy Participants
NCT01220167Enrollment18StartAug 2008Primary CompletionAug 2008CompletionAug 2008 - Phase 1Completed
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects
DESF
Allergic Reaction
NCT07703982Enrollment32StartDec 2024Primary CompletionMar 2025CompletionMay 2025
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category | NCT03428360 |
| Phase 2 | Completed | Diazepam Buccal Film 12.5 mg | NCT03179891 |
| Phase 2 | Completed | Diazepam Buccal Film | NCT03222349 |
| Phase 2 | Withdrawn | Riluzole Oral Soluble Film | NCT03457753 |
| Phase 2 | Terminated | Riluzole Oral Soluble film (ROSF) 50 mg | NCT03679975 |
| Phase 2 | Completed | DESF, Epinephrine Injection | NCT06527937 |
| Phase 1/2 | Completed | Ondansetron (ODFS), Zofran (ODT) | NCT01217190 |
| Phase 1/2 | Completed | Diazepam Buccal Film, Diastat® Rectal Gel (Valeant Pharmaceuticals USA) | NCT03953820 |
| Phase 1 | Completed | Ondansetron (ODFS), Ondansetron (ODT) | NCT01217801 |
| Phase 1 | Completed | Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water | NCT01220167 |
| Phase 1 | Completed | DESF | NCT07703982 |