TikTok U.S. Deal Advances as ByteDance Signs Binding Joint Venture Agreement 
ANZ New CEO Forgoes Bonus After Shareholders Reject Executive Pay Report 
Union-Aligned Investors Question Amazon, Walmart and Alphabet on Trump Immigration Policies 
Harris Associates Open to Revised Paramount Skydance Bid for Warner Bros Discovery 
Dina Powell McCormick Resigns From Meta Board After Eight Months, May Take Advisory Role 
Elon Musk Wins Reinstatement of Historic Tesla Pay Package After Delaware Supreme Court Ruling 
LG Energy Solution Shares Slide After Ford Cancels EV Battery Supply Deal 
FDA Fast-Tracks Approval of Altria’s on! PLUS Nicotine Pouches Under New Pilot Program 
U.S. Lawmakers Urge Pentagon to Blacklist More Chinese Tech Firms Over Military Ties 
Micron Technology Forecasts Surge in Revenue and Earnings on AI-Driven Memory Demand 
OpenAI Explores Massive Funding Round at $750 Billion Valuation 
Volaris and Viva Agree to Merge, Creating Mexico’s Largest Low-Cost Airline Group 
Elliott Management Takes $1 Billion Stake in Lululemon, Pushes for Leadership Change 
FedEx Beats Q2 Earnings Expectations, Raises Full-Year Outlook Despite Stock Dip 
Google and Apple Warn U.S. Visa Holders to Avoid International Travel Amid Lengthy Embassy Delays 
Trump Administration Reviews Nvidia H200 Chip Sales to China, Marking Major Shift in U.S. AI Export Policy 
Maersk Vessel Successfully Transits Red Sea After Nearly Two Years Amid Ongoing Security Concerns 
WARREN N.J., Jan. 06, 2017 -- MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced the completion of a dose proportionality study evaluating Diazepam Buccal Soluble Film (Diazepam BSF) for the treatment of Acute Repetitive Seizures (ARS).
Diazepam BSF, based on MonoSol Rx’s proprietary and patented PharmFilm technology, is a benzodiazepine used to treat ARS, as well as a variety of other indications including anxiety disorders, alcohol withdrawal symptoms, muscle spasms and seizures. The only product currently indicated for ARS is Diastat Rectal Gel. MonoSol Rx’s Diazepam BSF could potentially be the first and only oral treatment available for ARS sufferers.
The results show that MonoSol Rx’s Diazepam BSF is linear across all dosage strengths. This compares favorably to publicly available data for other alternative diazepam dosage forms. Based on this comparison, MonoSol Rx plans to initiate a pivotal study of Diazepam BSF in adults with ARS in the first quarter of 2017.
“We are extremely excited by the results of this study, which demonstrate that the pharmacokinetic profile of Diazepam BSF is consistent across dose strengths,” said Keith Kendall, CEO of MonoSol Rx. “We believe that Diazepam BSF will be able to overcome the many challenges associated with alternate delivery methods of this molecule and offers the potential to improve outcomes for ARS patients in need. We look forward to the continued progress of our Diazepam BSF program in the coming months.”
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug delivery technology to develop products that improve patient outcomes and address unmet needs. PharmFilm can benefit patients by improving the efficacy, safety, convenience, compliance and pharmacoeconomics of pharmaceutical products. MonoSol Rx's leadership in film drug technology is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com.
Contact MonoSol Rx Jessica Patel [email protected] The Ruth Group Lee Roth [email protected] (646) 536-7012
