Weight-Loss Drug Ads Take Over the Super Bowl as Pharma Embraces Direct-to-Consumer Marketing 
Once Upon a Farm Raises Nearly $198 Million in IPO, Valued at Over $724 Million 
OpenAI Expands Enterprise AI Strategy With Major Hiring Push Ahead of New Business Offering 
Rio Tinto Shares Hit Record High After Ending Glencore Merger Talks 
Trump Backs Nexstar–Tegna Merger Amid Shifting U.S. Media Landscape 
Ford and Geely Explore Strategic Manufacturing Partnership in Europe 
Baidu Approves $5 Billion Share Buyback and Plans First-Ever Dividend in 2026 
Toyota’s Surprise CEO Change Signals Strategic Shift Amid Global Auto Turmoil 
TSMC Eyes 3nm Chip Production in Japan with $17 Billion Kumamoto Investment 
Instagram Outage Disrupts Thousands of U.S. Users 
SoftBank Shares Slide After Arm Earnings Miss Fuels Tech Stock Sell-Off 
American Airlines CEO to Meet Pilots Union Amid Storm Response and Financial Concerns 
Amazon Stock Rebounds After Earnings as $200B Capex Plan Sparks AI Spending Debate 
Hims & Hers Halts Compounded Semaglutide Pill After FDA Warning 
Washington Post Publisher Will Lewis Steps Down After Layoffs 
Missouri Judge Dismisses Lawsuit Challenging Starbucks’ Diversity and Inclusion Policies 
Global PC Makers Eye Chinese Memory Chip Suppliers Amid Ongoing Supply Crunch 
ROCKVILLE, Md., April 05, 2017 -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced that the Food and Drug Administration (FDA) has granted final approval to the Company’s Supplemental New Drug Applications (sNDAs) requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults and adolescents 12 years and older. Supernus was granted tentative approval of one of the two sNDAs in August 2016, with final approval subject to the pediatric exclusivity of the innovator’s drug in the adolescent population, which expired March 28, 2017.
Based on IMS prescription data, Topiramate is the most prescribed drug for the treatment of migraine prophylaxis with more than 9 million prescriptions annually. This represents approximately 50% of all IMS prescriptions written for migraine prophylaxis.
“This approval and our imminent launch in migraine represent an opportunity for Supernus to further strengthen its leadership position in this market with Trokendi XR,” stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to the immediate-release topiramate products, making it an important new treatment option for adult and adolescent patients suffering from migraine headache. This is an important advancement for patients and another step towards realizing the full potential of Trokendi XR.”
About Trokendi XR
Trokendi XR is a novel once-daily extended release formulation of topiramate for the treatment of epilepsy, and migraine prophylaxis. Trokendi XR is indicated for the prophylaxis of migraine headache in adults and adolescents 12 years of age and older, initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome. The product is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
For current full prescribing and safety information, click here.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company has two marketed products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients and SPN-812 for the treatment of ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s ability to market Trokendi XR® in the migraine market. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the ability of the Company to increase the number of prescriptions written for each of its products and the Company's ability to increase its net revenue. For a further description of these and other risks facing the Company, please see the risk factors described in the Company’s 2016 Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission on March 16, 2017 under the caption “Risk Factors”. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as may be required by law.
Contact: Jack A. Khattar, President and CEO Gregory S. Patrick, Vice President and CFO Supernus Pharmaceuticals, Inc. 301-838-2591 Or Investor Contact: Peter Vozzo Westwicke Partners Office: (443) 213-0505 Mobile: (443) 377-4767 Email: [email protected]
