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WARREN, N.J., Nov. 2, 2018 /PRNewswire/ — Aquestive Therapeutics, Inc. AQST, 13.71% a specialty biologic company, today appear that the U.S. Food and Biologic Administering (FDA) accustomed SYMPAZAN [™] (clobazam) articulate blur for the accessory analysis of seizures associated with Lennox-Gastaut affection (LGS) in patients 2 years of age or older. [1] SYMPAZAN is the aboriginal and alone articulate blur FDA-approved to amusement seizures associated with LGS. Previously, clobazam was marketed as ONFI® and offered in two formulations – either book or articulate suspension. [2]

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“Aquestive Therapeutics is admiring to accompany SYMPAZAN to the LGS community,” said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. “Treating LGS can be difficult; patients may accept a adamantine time burning articulate medications. We’re optimistic SYMPAZAN can advice abode unmet medical needs and be an important analysis advantage for this accommodating population.”

LGS is a astringent anatomy of attack that begins in aboriginal adolescence and is characterized by assorted types of seizures and bookish disability. [3 ] LGS patients about accept adversity burning pills and ample aggregate suspensions due to concrete limitations, behavioral or cerebral impact. [4,5 ] Challenges with analysis administering can beforehand to ambiguous and inconsistent dosing, and access the accountability of care, decidedly for patients that may be antagonistic or aggressive to treatment. [5-] [8]

Since FDA approval in 2011, clobazam tablets and articulate abeyance (brand name ONFI®) accept been a trusted accessory analysis for LGS. In a Appearance 3, randomized, double-blind, placebo-controlled abstraction of 238 LGS patients, clobazam tablets decidedly bargain the abundance of bead seizures (which absorb falls) compared to baseline by 41 percent (low dose) to 68 percent (high dose) vs. 12 percent for placebo (p<0.05 for all doses vs. placebo). [2,9] Please see added Important Assurance Advice below, including the Boxed Warning on the risks associated with accessory use of opioids.

“Many LGS patients accept a adamantine time burning pills and suspensions. This can accomplish administering medication adamantine for caregivers,” says Christina SanInocencio, Executive Director of the LGS Foundation. “We accept SYMPAZAN will be accustomed by patients and caregivers impacted by LGS and analytic for analysis solutions.”

SYMPAZAN is a conception based on Aquestive’s accurate PharmFilm® technology. Assorted pharmacokinetic studies were conducted to analyze SYMPAZAN with ONFI. Based on the studies, SYMPAZAN articulate blur was approved to be bioequivalent to clobazam tablets and accept commensurable assurance profiles. [1] Aquestive’s analytic development of SYMPAZAN followed the 505(b)(2) authoritative pathway. 

“SYMPAZAN is the alpha of a allusive CNS authorization for Aquestive,” Kendall says. “We are actively alive to beforehand added redesigned, proprietary treatments that can action allusive improvements for patients and caregivers who alive with attack and added circuitous conditions.”

Aquestive affairs to commercialize SYMPAZAN in November, and has affianced Ashfield Healthcare, a aggregation specializing in commercialization services, to body and alternation a awful qualified, civic sales force. The sales force will focus on pediatric neurologists and epileptologists.

SYMPAZAN articulate blur is drupe flavored and offered in 5 mg, 10 mg, and 20 mg dosages to accommodated a ambit of LGS accommodating and caregiver needs. [1]

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About Aquestive Therapeutics Aquestive Therapeutics is a specialty biologic aggregation committed to identifying, developing and commercializing differentiated articles to abode unmet medical needs. Aquestive Therapeutics has a late-stage proprietary artefact activity focused on the analysis of CNS diseases, and is alive to beforehand orally-administered circuitous molecules that it believes can be alternatives to invasively-administered accepted of affliction therapies. As the baton in developing and carrying drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with biologic ally to accompany new molecules to bazaar in differentiated and highly-marketable dosage forms.

IMPORTANT SAFETY INFORMATION  BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Accessory use of benzodiazepines and opioids may aftereffect in abstruse sedation, respiratory depression, coma, and death.

p>CONTRAINDICATIONS SYMPAZAN is contraindicated in patients with a history of hypersensitivity to the biologic or its ingredients. Hypersensitivity reactions accept included austere dermatological reactions.

WARNINGS AND PRECAUTIONS  Potentiation of Balance from Accessory Use with Central Nervous System (CNS) Depressants SYMPAZAN has a CNS biologic effect. Caution patients and/or caregivers adjoin accompanying use with added CNS depressants or booze as the furnishings of added CNS depressants or booze may be potentiated.

Somnolence or Sedation  SYMPAZAN causes dose-related blackout and sedation, which about begins aural the aboriginal ages of analysis and may abate with connected treatment. Monitor patients for blackout and sedation, decidedly with accessory use of added CNS depressants. Caution patients adjoin agreeable in chancy activities acute brainy alertness, i.e., operating alarming accouterment or motor vehicles, until the aftereffect of SYMPAZAN is known.

Withdrawal Symptoms  Abrupt cessation of SYMPAZAN should be avoided. The accident of abandonment affection is greater with college doses. Withdraw SYMPAZAN gradually to abbreviate the accident of bottomward seizures, access exacerbation, or cachet epilepticus.

Serious Dermatological Reactions  Austere bark reactions, including Stevens-Johnson affection (SJS) and baneful epidermal necrolysis (TEN), accept been appear with clobazam in both accouchement and adults. Abandon SYMPAZAN at the aboriginal assurance of rash, unless the adventurous is acutely not drug-related.

Physical and Psychological Dependence  Patients with a history of actuality corruption should be beneath accurate surveillance back accepting SYMPAZAN.

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Suicidal Behavior and Ideation  AEDs, including SYMPAZAN, access the accident of baleful thoughts or behavior in patients. Patients advised with SYMPAZAN should be monitored for the actualization or deepening of depression, baleful thoughts or behavior, and/or any abnormal changes in affection or behavior. Inform patients, their caregivers, and families of the added accident of baleful thoughts and behaviors. Advise them to be active for and address anon to healthcare providers any actualization or deepening signs and affection of depression, any abnormal changes in affection or behavior, or the actualization of baleful thoughts, behavior, or thoughts of self-harm.

ADVERSE REACTIONS  Adverse reactions (≥10% and added frequently than placebo) included constipation, blackout or sedation, pyrexia, lethargy, and drooling.

DRUG INTERACTIONS   The accessory use of benzodiazepines and opioids increases the accident of respiratory depression. Limit dosage and continuance of accessory use of benzodiazepines and opioids and chase patients carefully for respiratory abasement and sedation. Accessory use of SYMPAZAN with added CNS depressants, including alcohol, may access the accident of balance and somnolence. Caution patients and/or caregivers adjoin accompanying use with added CNS depressants or alcohol, as furnishings of added CNS depressants or booze may be potentiated. Hormonal contraceptives that are metaized by CYP3A4; capability may be beneath back accustomed with SYMPAZAN. Additional non-hormonal forms of contraception are recommended back application SYMPAZAN. Dosage acclimation may be all-important of drugs metaized by CYP2D6 and of SYMPAZAN back co-administered with able CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine).

USE IN SPECIFIC POPULATIONS  Abundance and Lactation: SYMPAZAN may account fetal abuse and should alone be acclimated during abundance if the abeyant account justifies the abeyant accident to the fetus. Breed built-in to mothers who accept taken benzodiazepines during the afterwards stages of abundance can advance dependence, abandonment affection and affection evocative of billowing baby syndrome. SYMPAZAN is excreted in animal milk. Because of the abeyant for austere adverse reactions in nursing breed from SYMPAZAN, abandon nursing or abandon the drug. Encourage patients to alarm the toll-free cardinal 1-888-233-2334 to accept in the Abundance Registry or appointment http://www.aedpregnancyregistry.org/.

You are encouraged to address abrogating ancillary furnishings of decree drugs to the FDA. Appointment www.fda.gov/medwatch, or alarm 1-800-FDA-1088.

Please bang actuality to see abounding Prescribing Information, including Boxed Warning.

Forward-Looking Account This columnist absolution contains advanced statements aural the acceptation of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “could,” “estimate,” “expects,” “intend,” “may,” “plan,” “potential,” “project,” “will,” “would,” or the abrogating of those terms, and agnate expressions, are advised to analyze advanced statements. Such statements include, but are not bound to, statements about authoritative approvals and pathways, analytic balloon timing and plans, the accomplishment of analytic and bartering milestones, approaching banking and operating results, business strategies, bazaar opportunities, financing, and added statements that are not absolute facts.

These advanced statements are based on our accepted expectations and behavior and are accountable to a cardinal of risks and uncertainties that could account absolute after-effects to alter materially from those declared in the advanced statements. Such risks and uncertainties include, but are not bound to, risks associated with the Company’s development work, including any delays or changes to the timing, amount and success of our artefact development activities and analytic trials; the risks of delays in FDA approval of our biologic candidates or abortion to accept approval; the risks inherent in commercializing a new artefact (including technology risks, banking risks, bazaar risks and accomplishing risks and authoritative limitations); development of our sales and business capabilities; the amount and amount of bazaar accepting of our artefact candidates; the success of any aggressive products; the admeasurement and advance of our artefact markets; the capability and assurance of our artefact candidates; risks associated with bookish acreage rights and infringement; abrupt apparent developments; and added risks and uncertainties affecting the Aggregation including those declared in the “Risk Factors” area included in our Registration Account on Anatomy S-1 declared able by the SEC on July 24, 2018. As with any biologic artefact applicant beneath development, there are cogent risks with account to the development, authoritative approval and commercialization of new products. Accustomed these uncertainties, you should not abode disproportionate assurance on these advanced statements, which allege alone as of the date made. All consecutive advanced statements attributable to us or any being acting on our account are especially able in their absoluteness by this cautionary statement. We accept no obligation to amend our advanced statements afterwards the date of this columnist absolution whether as a aftereffect of new information, approaching contest or otherwise, except as may be appropriate beneath applicative law.

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Media inquiries: Christopher [email protected] 212-364-0458

Investor inquiries: Stephanie [email protected] 646-277-1282

References:

1.

Aquestive Data on File. [SYMPAZAN Prescribing Information]. Warren, NJ: Aquestive Therapeutics Inc; 2018.

2.

ONFI [package insert]. Deerfield, IL: Lundbeck; 2011.

3.

Middle Georgia Pediatrics, L.L.C
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Lennox-Gastaut syndrome. Civic Institutes of Health. https://ghr.nlm.nih.gov/condition/lennox-gastaut-syndrome. Published 2018. Accessed November 1, 2018.

4.

Ogawa K, Kanemoto K, Ishii Y, Koyama M, Sirasaka Y, Kawasaki J, Yamasaki S. Long-term aftereffect abstraction of Lennox–Gastaut affection in patients with astringent motor and bookish disabilities: with appropriate advertence to the botheration of dysphagia. Seizure. 2001; 10:197-202.

5.

LGS Foundation. About Lennox-Gastaut Syndrome. Available at: http://www.lgsfoundation.org/aboutlgs. Accessed November 1, 2018.

6.

Clobazam. Medline Plus. https://medlineplus.gov/druginfo/meds/a612008.html. Accessed October 25, 2018.

7.

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Patient Login – pediatric new patient registration form | pediatric new patient registration form

Living with LGS. About Lennox-Gastaut Syndrome. Available at: http://www.lgsfoundation.org/livingwithlgs. Accessed November 1, 2018.

8.

Verrotti A., Coppola G., Fiordaliso L., D’Egidio C., Loiacono G., Chiarelli F. New antiepileptic drugs in the analysis of Lennox-Gastaut syndrome. Journal of Pediatric Sciences. 2009;1:e16.

9.

Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Abstraction Investigators. Randomized, appearance III abstraction after-effects of clobazam in Lennox-Gastaut syndrome. Neurology. 2011 Oct 11;77(15):1473-81.

View aboriginal content:http://www.prnewswire.com/news-releases/aquestive-therapeutics-announces-us-food-and-drug-administration-fda-approval-for-sympazan-clobazam-oral-film-300742913.html

SOURCE Aquestive Therapeutics, Inc.

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