Pipeline

An expanding portfolio

Aquestive Therapeutics is the undisputed leader in developing and delivering medications via film, through PharmFilm® technology. Building on this success, we have established a robust portfolio of treatments for CNS disorders and are advancing a late-stage pipeline with promising treatments for complex conditions.

Reinventing medicines

Our investigational medicines can offer simple new ways for patients and caregivers to use proven and trusted molecules. Our late-stage pipeline includes several investigational treatments for CNS conditions, where patients face great difficulty in using medication because of the impact of their disease.1 Looking ahead, we see even greater potential for PharmFilm® technology to improve patient treatment and are working to deliver complex molecules, proteins, and peptides on oral film with newer prodrugs and technologies.

Product Pipeline

Click for details
Program
Molecule
Indication
Formulation    Pre-Clinical    Phase 1    Phase 2    Phase 3    Filed    Marketed
CNS Programs
SYMPAZAN®
clobazam
Lennox-Gastaut syndrome

Marketed

  • Indicated to treat Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

Status

  • Received FDA approval, November 1, 2018

Highlights

LibervantTM*
diazepam
Breakthrough Seizures

Phase 3

  • In development as an oral rescue therapy for breakthrough seizures

Status

  • Phase 3

Highlights

  • Diazepam buccal film may address issues of invasiveness and consistency of absorption, with current standard of care — DIASTAT® (diazepam rectal gel)
ExservanTM*
riluzole
ALS

Filed

  • In development as a treatment for amyotrophic lateral sclerosis (ALS)

Status

  • Filed

Highlights

  • Dysphagia affects many people with ALS type 1
  • ExservanTM may improve the ability of sufferers to use riluzole, proven to extend life and time to tracheotomy
Complex Molecule Programs
AQST-108
epinephrine
Anaphylaxis, severe allergy

Phase 1

  • In development as a treatment for anaphylaxis, severe allergy

Status

  • Phase 1

Highlights

  • Anaphylaxis may impact as many as 1 in 20 people in the United States2-4
  • Potential to be the first oral version of epinephrine available as a therapeutic solution for anaphylaxis
AQST-305
octreotide
Acromegaly / Carcinoid syndrome

Pre-Clinical

  • In development as a treatment for patients with acromegaly and neuroendocrine tumors

Status

  • Pre-Clinical, proof of concept clinical studies in progress

Highlight

  • Potential to decrease or possibly eliminate the burden associated with monthly depot intramuscular injections of octreotide
Licensed programs
SUBOXONE
(Partner: Indivior)
buprenorphine / naloxone
Opioid Dependence

Marketed since 2010

  • Indicated to treat opioid dependency

Status

  • Marketed since 2010

Highlights

ZUPLENZ
(Partner: Midatech)
ondansetron
CINV / PINV

Marketed since 2010

  • Anti-emetic treatment for patients receiving chemotherapy, radiation therapy, or surgery

Status

  • Marketed since 2010

Highlights

APL-130277
(Partner: Sunovion)
apomorphine
Parkinson’s Disease

Filed

  • In development as a treatment for Parkinson’s disease

Status

  • Filed

Highlight

  • Potential to provide an alternate delivery method for patients with loss of body movement
AQST-119
(Partner: IntelGenx)
tadalafil
Erectile Dysfunction / BPH

Filed

  • In development as a therapy for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia

Status

  • Filed

Highlight

  • Potential to provide an alternate delivery method for those with erectile dysfunction

*Aquestive has received conditional acceptance of the use of this trade name, which is subject to final FDA review and acceptance

Subject to review, evaluation, and approval of the FDA

 

Essential information for the investment community

Aquestive sponsored clinical trials

Clinical trial news and other updates

References

1. Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747–753.

2. Fischer D, Vander Leek TK, Ellis AK, Kim H. Anaphylaxis. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):54

3. Wood RA, Camargo CA Jr, Lieberman P, et al. Anaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United States. J Allergy Clin Immunol. 2014 Feb;133(2):461-467.

4. Ma L, Danoff TM, Borish L. Case fatality and population mortality associated with anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(4):1075-1083.

Sympazan® is a registered trademark of Aquestive Therapeutics, Inc.
SUBOXONE® is a registered trademark of Indivior UK Ltd.
ZUPLENZ® is a registered trademark of Midatech Pharma US Inc.
DIASTAT® is a registered trademark of Bausch Health Companies, Inc.

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Please complete this form:

  • To subscribe to receive marketing 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. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing clinicaltrials@aquestive.com.

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:

  • 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.

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