Apple Explores India for iPhone Chip Assembly as Manufacturing Push Accelerates 
Oracle Stock Slides After Blue Owl Exit Report, Company Says Michigan Data Center Talks Remain on Track 
Oracle Stock Surges After Hours on TikTok Deal Optimism and OpenAI Fundraising Buzz 
LG Energy Solution Shares Slide After Ford Cancels EV Battery Supply Deal 
Sanofi’s Efdoralprin Alfa Gains EMA Orphan Status for Rare Lung Disease 
noyb Files GDPR Complaints Against TikTok, Grindr, and AppsFlyer Over Alleged Illegal Data Tracking. 
Micron Technology Forecasts Surge in Revenue and Earnings on AI-Driven Memory Demand 
MetaX IPO Soars as China’s AI Chip Stocks Ignite Investor Frenzy 
OpenAI Explores Massive Funding Round at $750 Billion Valuation 
Citi Appoints Ryan Ellis as Head of Markets Sales for Australia and New Zealand 
Toyota to Sell U.S.-Made Camry, Highlander, and Tundra in Japan From 2026 to Ease Trade Tensions 
Volaris and Viva Agree to Merge, Creating Mexico’s Largest Low-Cost Airline Group 
ANZ New CEO Forgoes Bonus After Shareholders Reject Executive Pay Report 
Shell M&A Chief Exits After BP Takeover Proposal Rejected 
Maersk Vessel Successfully Transits Red Sea After Nearly Two Years Amid Ongoing Security Concerns 
Blackstone Leads $400 Million Funding Round in Cyera at $9 Billion Valuation 
Apple Opens iPhone to Alternative App Stores in Japan Under New Competition Law 
WARREN, N.J., Jan. 05, 2017 -- MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for Riluzole Oral Soluble Film (Riluzole OSF) for the treatment of Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s Disease”).
The accepted IND outlines MonoSol Rx’s clinical development plans for Riluzole OSF for the treatment of ALS. Riluzole is a glutamine blocker currently available in a tablet formulation. It has been shown to delay the onset of ventilator dependence or tracheostomy in select ALS patients, and may increase survival by two to three months. Its use has also been studied in mood and anxiety disorders as well as Alzheimer’s Disease.
“ALS is a highly debilitating neurodegenerative disease that has a tremendous impact on patients’ and caregivers’ lives. Progressive difficulties in swallowing is a well-known characteristic of this disease state. We believe that Riluzole OSF may provide significant advantages over the current routes of administration,” said Keith Kendall, CEO of MonoSol Rx. “We are pleased that the FDA has accepted our IND and look forward to initiating our pivotal pharmacokinetic clinical study for Riluzole OSF.”
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, and convenience of pharmaceutical and over-the counter products. MonoSol Rx 's leadership in film drug delivery 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
