Benzodiazepines

Benzodiazepine Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018 - 2026

Retrieved on: 
Monday, February 25, 2019
Psychoactive drugs, GABAA receptor positive allosteric modulators, Chemical compounds, Drugs, Chloroarenes, Benzodiazepines, Anxiolytics, RTT, Benzodiazepine, Lorazepam, Alprazolam, Diazepam

Moreover, a comparatively higher number of prescriptions of benzodiazepine, as compared to other psychoactive drugs, and an increase in the rate of adoption of generic drugs have fuelled the benzodiazepine drugs market.

Key Points: 
  • Moreover, a comparatively higher number of prescriptions of benzodiazepine, as compared to other psychoactive drugs, and an increase in the rate of adoption of generic drugs have fuelled the benzodiazepine drugs market.
  • The benzodiazepine drugs market has been segmented based on product, application, time of action, distribution channel, and region.Based on product, the global market has been divided into Alprazolam, Clonazepam, Diazepam, Lorazepam, and others.
  • The market overview section of the report demonstrates the market dynamics and market trends such as drivers, restraints, opportunities and key trends that influence the current and future status of the benzodiazepine drugs market.
  • The report also covers market value projections, market attractiveness analysis, and key market share analysis in the market overview section in order to provide a thorough analysis of the overall competitive scenario of the global benzodiazepine drugs market.

Aquestive Therapeutics Provides End of Year Business Update, Including Progress of its Proprietary CNS Assets, Financial and Legal Matters

Retrieved on: 
Thursday, December 20, 2018
Neurochemistry, GABAA receptor positive allosteric modulators, RTT, Chemistry, Medicine, Benzodiazepines, Chloroarenes, Lactams, Riluzole, Diazepam, Buccal, Cheek

With the product now in channel, sales and marketing plans are being executed to activate customer demand and new prescriptions.

Key Points: 
  • With the product now in channel, sales and marketing plans are being executed to activate customer demand and new prescriptions.
  • Aquestive is developing diazepam buccal film (DBF or Libervant) for the treatment of seizure clusters in patients with refractory epilepsy.
  • Libervant is a novel formulation of diazepam as a small, thin film strip for placement inside the cheek.
  • Aquestive is also planning to submit an NDA in January 2019 for riluzole oral film (ROF or Exservan).

Vanda Announces Positive Pivotal Study Results for HETLIOZ® (tasimelteon) in Patients with Smith-Magenis Syndrome

Retrieved on: 
Monday, December 10, 2018
RTT, Benzodiazepines, Fluoroquinolone antibiotics, Piperazines, Depression, Chemistry, Organic chemistry

The Vanda management team will host a conference call and live webcast today, Monday, December 10, 2018, at 8:30 AM ET to discuss these updates.

Key Points: 
  • The Vanda management team will host a conference call and live webcast today, Monday, December 10, 2018, at 8:30 AM ET to discuss these updates.
  • The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZis increased by approximately 2-fold compared with younger patients.
  • The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZis increased by approximately 2-fold compared with younger patients.
  • Vanda is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.

Aquestive Therapeutics Launches SYMPAZAN™ (clobazam) Oral Film with Widespread U.S. Availability

Retrieved on: 
Thursday, November 29, 2018
GABAA receptor positive allosteric modulators, Lactams, Benzodiazepines, Chloroarenes, Clobazam, Chemistry, Depressant

WARREN, N.J., Nov.29, 2018 /PRNewswire/ --Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, today announced it has launched SYMPAZAN (clobazam) oral film with availability nationwide through retail pharmacies and mail order.

Key Points: 
  • WARREN, N.J., Nov.29, 2018 /PRNewswire/ --Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, today announced it has launched SYMPAZAN (clobazam) oral film with availability nationwide through retail pharmacies and mail order.
  • Multiple pharmacokinetic studies were conducted to compare SYMPAZAN with clobazam tablets and oral suspension (brand name ONFI).
  • 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.
  • Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants SYMPAZAN has a CNS depressant effect.

Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Approval for SYMPAZAN™ (clobazam) Oral Film

Retrieved on: 
Friday, November 2, 2018
Chemistry, Pharmacology, Medicine, RTT, Chloroarenes, GABAA receptor positive allosteric modulators, Benzodiazepines, Clobazam, Lactams, Bioequivalence, Medroxyprogesterone acetate, Paracetamol

Previously, clobazam was marketed as ONFI and offered in two formulations either tablet or oral suspension.2

Key Points: 
  • Previously, clobazam was marketed as ONFI and offered in two formulations either tablet or oral suspension.2
    "Aquestive Therapeutics is pleased to bring SYMPAZAN to the LGS community," saidKeith J. Kendall, Chief Executive Officer of Aquestive Therapeutics.
  • 5-8
    Since FDA approval in 2011, clobazam tablets and oral suspension (brand name ONFI) have been a trusted adjunctive treatment for LGS.
  • "We believe SYMPAZAN will be welcomed by patients and caregivers impacted by LGS and searching for treatment solutions."
  • Based on the studies, SYMPAZAN oral film was demonstrated to be bioequivalent to clobazam tablets and have comparable safety profiles.1 Aquestive's clinical development of SYMPAZAN followed the 505(b)(2) regulatory pathway.

Upsher-Smith Launches Generic Version Of Onfi® (clobazam), CIV In Tablet And Oral Suspension Dosage Forms

Retrieved on: 
Tuesday, October 23, 2018
GABAA receptor positive allosteric modulators, Neurochemistry, Lactams, Benzodiazepines, Chloroarenes, Chemistry, Medicine, Clobazam, Food and Drug Administration, MedWatch, Adverse effect, Opioid

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Key Points: 
  • 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.
  • Please refer to the full Prescribing Information, including Boxed Warning for Clobazam Tablets, CIV here and for Clobazam Oral Suspension, CIV here .
  • You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch .

Breckenridge Announces Final Approval of its ANDA for Clobazam Tablets (Generic for Onfi®)

Retrieved on: 
Tuesday, October 23, 2018
GABAA receptor positive allosteric modulators, Lactams, Benzodiazepines, Chloroarenes, Neurochemistry, Clobazam, Chemistry, Lundbeck, Lennox–Gastaut syndrome, Neurology, Diazepine, LGS

BOCA RATON, Fla., Oct. 23, 2018 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi Tablets by Lundbeck.

Key Points: 
  • BOCA RATON, Fla., Oct. 23, 2018 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi Tablets by Lundbeck.
  • Breckenridge's Clobazam product was developed by its vertically integrated manufacturing partner and will be available in 10mg and 20mg tablets.
  • Clobazam Tablets are a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
  • The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide.

Amneal Announces Approval and Launch of Clobazam Tablets and Clobazam Oral Suspension

Retrieved on: 
Tuesday, October 23, 2018
GABAA receptor positive allosteric modulators, Chloroarenes, Benzodiazepines, Clobazam, Lactams, Amneal Pharmaceuticals

BRIDGEWATER, N.J., Oct. 23, 2018 /PRNewswire/ -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of Onfi (clobazam) tablets, 10 mg and 20 mg for oral use, CIV, and Onfi (clobazam) oral suspension, 2.5 mg/mL ,CIV.

Key Points: 
  • BRIDGEWATER, N.J., Oct. 23, 2018 /PRNewswire/ -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of Onfi (clobazam) tablets, 10 mg and 20 mg for oral use, CIV, and Onfi (clobazam) oral suspension, 2.5 mg/mL ,CIV.
  • "Amneal is pleased to receive approval on our clobazam tablets and clobazam oral suspension ANDAs," said Andy Boyer, Executive Vice President of Commercial Operations for Amneal.
  • According to IQVIA, U.S market annual sales for the 12 months ended August 2018 for Clobazam Tablets is estimated to be approximately $594 million and for Clobazam oral suspension is estimated to be approximately $255 million.
  • See the Full Prescribing Information, for Clobazam Tablets, CIV at https://www.amneal.com/wp-content/uploads/2018/10/Clobazam-Tablets-PI.pdf .

Neurelis Files New Drug Application With The FDA For VALTOCO™ Nasal Spray, An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients

Retrieved on: 
Tuesday, September 25, 2018
GABAA receptor positive allosteric modulators, Neurochemistry, RTT, Chloroarenes, Lactams, Chemistry, Benzodiazepines, Clinical medicine, Diazepam, Epilepsy

Earlier this year, the FDA provided conditional acceptance for use of the name "VALTOCO" for the product previously referred to in clinical development as "NRL-1."

Key Points: 
  • Earlier this year, the FDA provided conditional acceptance for use of the name "VALTOCO" for the product previously referred to in clinical development as "NRL-1."
  • VALTOCO, Neurelis' lead product candidate, is a proprietary formulation of diazepam incorporating the unique combination of a vitamin E-based solution and Intravail absorption enhancement.
  • "Cluster or acute repetitive seizures are both dangerous and highly disruptive in the lives of epilepsy patients," said Neurelis President and CEO Craig Chambliss.
  • "VALTOCO was developed to provide an effective combination of reliability, safety, and tolerability in a simple, ready-to-use nasal spray."

Quest Diagnostics Health Trends™ Study Finds Drug Misuse Rates Remain Constant at High Levels, and Dangerous Opioid-related Drug Combining Is Prevalent

Retrieved on: 
Thursday, September 6, 2018
GABAA receptor positive allosteric modulators, Benzodiazepines, Substance dependence, Chloroarenes, Hypnotics, Neurochemistry

"The majority of patients continue to show evidence of drug misuse, and this problem affects all age groups and both genders.

Key Points: 
  • "The majority of patients continue to show evidence of drug misuse, and this problem affects all age groups and both genders.
  • When it comes to drug misuse, everyone is at risk," said lead author F. Leland McClure, PhD, MSci, F-ABFT, director, medical science liaison, medical affairs, Quest Diagnostics.
  • "The overall rate of misuse did not change, but our data found significant shifts in the nature of the epidemic.
  • The Health Trends report additionally found that drug mixing is the most common type of misuse.