December, 20 2018 at 07:30 AM EST
Sympazan™ Launch Propels Aquestive's First Proprietary Franchise
With the product now in channel, sales and marketing plans are being executed to activate customer demand and new prescriptions. Aquestive's commercial team of 50+ experienced professionals have already completed thousands of interactions with local healthcare providers, payers that cover approximately 280 million lives, and pharmacists in markets nationwide. The company has also scheduled more than 40 speaker programs through
"The first scripts have been written and filled. We are very encouraged by the reception of Sympazan in the market and feel that our engagements with customers are positioning us well for the future launch of Libervant™, when approved," said
Regulatory Filings Are Advancing for Libervant™ and Exservan™ in 2019
Aquestive is developing diazepam buccal film (DBF or Libervant™) for the treatment of seizure clusters in patients with refractory epilepsy. The company recently held a pre-NDA (New Drug Application) meeting with the
"We are pleased with the feedback given by the
Libervant is a novel formulation of diazepam as a small, thin film strip for placement inside the cheek. Libervant leverages Aquestive's proprietary PharmFilm® technology and is in development for the management of select patients with refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity or seizure clusters. Currently, the only product with
Aquestive is also planning to submit an NDA in
Legal Proceedings and New Drivers of Suboxone® Film Business
"We will continue to work with
Aquestive's Suboxone revenues are driven by order volume from both branded and authorized generic products. Aquestive has a sole and exclusive worldwide manufacturing agreement with
Early Asset Pipeline Progressing
Several proprietary assets in early stages of development show promise for clinical advancement in 2019. Aquestive is continuing to optimize the formulations and advance proof-of-concept studies for AQST-108 (epinephrine) and AQST-305 (octreotide). Interactions with U.S. and ex-U.S. regulatory authorities and potential study investigators have provided valuable input into plans for clinical development. Additional clinical trials for both products will take place in 2019.
Solid Cash Position and Access to Non-Dilutive Capital Sources
Aquestive expects full-year 2018 revenues to be more than
"With the cash we have on-hand, along with cash generated by our ongoing business, and additional options to monetize non-strategic, partnered product royalty streams, we have the resources we need to fulfill our business plans," said Mr. Kendall.
Investment Community Conference Call
The company will host an investment community conference call at
Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.
SYMPAZAN IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
SYMPAZAN is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.
WARNINGS AND PRECAUTIONS
Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants SYMPAZAN has a CNS depressant effect. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS depressants or alcohol may be potentiated.
Somnolence or Sedation
SYMPAZAN causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous machinery or motor vehicles, until the effect of SYMPAZAN is known.
Abrupt discontinuation of SYMPAZAN should be avoided. The risk of withdrawal symptoms is greater with higher doses. Withdraw SYMPAZAN gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus.
Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults. Discontinue SYMPAZAN at the first sign of rash, unless the rash is clearly not drug-related.
Physical and Psychological Dependence
Patients with a history of substance abuse should be under careful surveillance when receiving SYMPAZAN.
Suicidal Behavior and Ideation
AEDs, including SYMPAZAN, increase the risk of suicidal thoughts or behavior in patients. Patients treated with SYMPAZAN should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients, their caregivers, and families of the increased risk of suicidal thoughts and behaviors. Advise them to be alert for and report immediately to healthcare providers any emergence or worsening signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.
Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation. Concomitant use of SYMPAZAN with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol may be potentiated.
Hormonal contraceptives that are metabolized by CYP3A4; effectiveness may be diminished when given with SYMPAZAN. Additional non-hormonal forms of contraception are recommended when using SYMPAZAN. Dose adjustment may be necessary of drugs metabolized by CYP2D6 and of SYMPAZAN when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine).
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation: SYMPAZAN may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. SYMPAZAN is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from SYMPAZAN, discontinue nursing or discontinue the drug. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit http://www.aedpregnancyregistry.org/.
You are encouraged to report negative side effects of prescription drugs to the
Please click here to see full Prescribing Information, including Boxed Warning.
This press release contains forward-looking statements within the meaning 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 negative of those terms, and similar expressions, are intended to identify forward-looking statements. Such statements include, but are not limited to, statements about regulatory approvals and pathways, clinical trial timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, business strategies, market opportunities, financing, and other statements that are not historical facts.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials; the risks of delays in
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