topiramate XR / Generic mfg. - LARVOL DELTA

Anti-obesity Pharmacotherapy and Inflammation (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Louisiana State University Health Sciences Center in New Orleans | Trial completion date: Jul 2025 ➔ Feb 2026 | Trial primary completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Inflammation • Obesity

Anti-obesity Pharmacotherapy and Inflammation (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Louisiana State University Health Sciences Center in New Orleans | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Jul 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Genetic Disorders • Inflammation • Obesity • Oncology

Therapy for Migraine Prevention in Children 6-11 Years of Age (clinicaltrials.gov) - P4 | N=26 | Terminated | Sponsor: Supernus Pharmaceuticals, Inc. | N=162 ➔ 26 | Trial completion date: Dec 2024 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ May 2024; Difficulty in recruitment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Migraine • Pain

Therapy for Migraine Prevention in Children 6-11 Years of Age (clinicaltrials.gov) - P4 | N=162 | Recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial primary completion date • CNS Disorders • Migraine • Pain

Anti-obesity Pharmacotherapy and Inflammation (clinicaltrials.gov) - P=N/A | N=24 | Recruiting | Sponsor: Louisiana State University Health Sciences Center in New Orleans | Trial completion date: Apr 2024 ➔ Dec 2024 | Trial primary completion date: Feb 2024 ➔ Sep 2024

Inflammatory cell • Trial completion date • Trial primary completion date • Genetic Disorders • Inflammation • Obesity • Oncology

Supernus Wins Infringement and Validity Case on Trokendi XR against Torrent (GlobeNewswire) - "Supernus Pharmaceuticals, Inc...announced today that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos. 8,992,989; 9,549,940; and 9,622,983 by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking permission to market a generic version of Trokendi XR before the expiration of Supernus’ patents."

ANDA • Corporate lawsuit • CNS Disorders • Migraine • Pain

Ajanta Pharma gets USFDA nod for migraine medicine topiramate extended-release capsules (CNBC-TV18) - "Drug maker Ajanta Pharma Ltd on Wednesday...said it has received the final approval from the United States Food and Drug Administration (USFDA) for marketing topiramate extended-release capsules in strengths of 25 mg, 50 mg, 100 mg, and 200 mg....Topiramate, in its extended-release form, is the generic counterpart of Supernus Pharmaceuticals Inc's Trokendi XR. It is used to treat seizures in people with epilepsy and prevent migraine."

ANDA • CNS Disorders • Migraine • Pain

Therapy for Migraine Prevention in Children 6-11 Years of Age (clinicaltrials.gov) - P4 | N=162 | Recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Supernus Announces First Quarter 2023 Financial Results (GlobeNewswire) - "In April 2023, the Company had a constructive meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter received in October 2022. Based on this meeting, the Company expects to resubmit the New Drug Application for SPN-830 in the fourth quarter of 2023....Net product sales were $140.6 million, compared to net product sales of $147.5 million for the same period in 2022. The decrease in net product sales was primarily due to a decrease in net product sales of Trokendi XR, partially offset by an increase in net product sales of both Qelbree and GOCOVRI. Excluding net product sales of Trokendi XR, first quarter 2023 total net product sales increased 25% compared to the same quarter last year."

FDA event • NDA • Sales • CNS Disorders • Parkinson's Disease

The top 10 drugs losing US exclusivity in 2023 (Fierce Pharma) - "Symbicort: 2022 U.S. sales: $973 million; Expected generic entry: July 2023....In 2022, Symbicort generated $2.54 billion worldwide, a 2% decline year over year at constant exchange rates. The U.S. chipped in $973 million, a 9% decline from the prior year....Trokendi XR (topiramate); 2022 U.S. sales: $261 million...It's going to be an important year for Supernus Pharmaceuticals as company's longtime top-seller, Trokendi XR, faces its first U.S. generic competition. Now, the company will have to rely on new growth drivers to withstand the hits to its star product."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • CNS Disorders • Epilepsy • Respiratory Diseases

Supernus Announces Fourth Quarter and Full Year 2022 Financial Results (Yahoo Finance) - "'In 2022, we continued to execute on our long-term growth strategy focusing on successfully transitioning from our legacy and mature products to our growth products, and finished the year with record revenues of $667.2 million, up 15% from the prior year'...'Based on this successful transition and with a solid foundation, we are confident that our growth drivers will allow us to offset the impact coming from loss of exclusivity for Trokendi XR and position us well to drive strong revenue and non-GAAP operating income growth in 2024 and beyond.'"

Commercial • CNS Disorders • Epilepsy

Zydus Lifesciences’ US subsidiary launches epilepsy treatment capsules (CNBC-TV18) - "Zydus Lifesciences on Friday announced the launch of Topiramate Extended-Release Capsules in the United States through its subsidiary Zydus Pharmaceuticals (USA) Inc. for the treatment of epilepsy."

Launch US • CNS Disorders • Epilepsy

SUPERNUS PHARMACEUTICALS, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) (Market Screener) - "Trokendi XR net product sales decreased by 13% to $62.8 million for the three months ended March 31, 2022 as compared to the same period in 2021. This decrease was attributable primarily to the decline in unit demand offset by the price increase taken in January 2022. APOKYN net product sales decreased by 15% to $18.4 million for the three months ended March 31, 2022 as compared to the same period in 2021. This decrease was primarily attributable to the decline in unit demand due to competitive headwinds."

Sales • CNS Disorders • Migraine • Pain • Parkinson's Disease

Therapy for Migraine Prevention in Children 6-11 Years of Age (clinicaltrials.gov) - P4; N=162; Recruiting; Sponsor: Supernus Pharmaceuticals, Inc.; Trial completion date: Mar 2021 ➔ Dec 2022; Trial primary completion date: Mar 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Supernus Announces Third Quarter 2021 Financial Results (GlobeNewswire) - "Supernus Pharmaceuticals, Inc...today reported financial results for the third quarter of 2021, and associated Company developments....Third quarter 2021 net product sales were $145.5 million, compared to $152.1 million in the same period in 2020. The decrease was primarily due to a decrease in net product sales of APOKYN and Trokendi XR..."

Sales • CNS Disorders • Migraine • Pain • Parkinson's Disease

Supernus sues Zydus again over generic Trokendi XR migraine, seizure drug (Reuters) - "Zydus allegedly infringed patents with proposed Trokendi generic....Complaint says Zydus not allowed to make generic until 2023....Supernus Pharmaceuticals sued Indian generic drugmaker Zydus Cadila and its U.S. subsidiary in Manhattan federal court on Friday for allegedly infringing 10 patents with its proposed generic of Supernus' top-selling drug for migraines and seizures."

Patent • CNS Disorders • Epilepsy • Migraine • Pain

EMPOWER-T2D: EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial (clinicaltrials.gov) - P4; N=300; Recruiting; Sponsor: The Cleveland Clinic; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Supernus Pharmaceuticals Inc (SUPN) Q3 2020 Earnings Call Transcript (The Motley Fool) - "...Our late stage pipeline...Apomorphine infusion pump or SPN-830...we plan to launch the product in the fourth quarter of 2021....Total revenue was comprised of net product sales of Trokendi XR and Oxtellar XR of $111.2 million, $40.9 million from the Parkinson's disease products and royalty revenue of $3 million....Our plan is to grow the franchise, the APOKYN product, the pen, the injection as well as the pump together as an Apomorphine franchise to be one of the leading franchises in Parkinson's."

Commercial • Launch US • Sales • CNS Disorders • Migraine • Pain • Parkinson's Disease

EMPOWER-T2D: EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial (clinicaltrials.gov) - P4; N=300; Not yet recruiting; Sponsor: The Cleveland Clinic

New P4 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Evolution of Pharmacological Obesity Treatments: Focus on Adverse Side-Effect Profiles. (PubMed) - "...Examples include pulmonary hypertension (aminorex), cardiovascular toxicity, e.g. flenfluramine-induced valvopathy, stroke [phenylpropanolamine (PPA)], excess non-fatal cardiovascular events (sibutramine), and neuro-psychiatric issues (rimonabant; approved in Europe, but not in the USA)...Thus, two drugs recently approved by the FDA, i.e. lorcaserin and phentermine + topiramate extended release, are not available in Europe. In contrast, naltrexone sustained release (SR)/bupropion SR received FDA approval, and liraglutide 3.0 mg was recently approved in both the USA and Europe. Regulatory strategies adopted by the FDA to manage the potential for uncommon but potentially serious post-marketing toxicity include: (a) Risk Evaluation and Mitigation Strategy (REMS) programs, (b) stipulating post-marketing safety trials, (c) considering responder rates and limiting cumulative exposure by discontinuation if weight loss is not attained within a reasonable timeframe, and (d) requiring..

Journal • Review • Biosimilar • Cardiovascular • Diabetes • Obesity

Therapy for Migraine Prevention in Children 6-11 Years of Age (clinicaltrials.gov) - P4; N=162; Recruiting; Sponsor: Supernus Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: Mar 2022 ➔ Mar 2021; Trial primary completion date: Nov 2021 ➔ Mar 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Migraine

Supernus Announces Preliminary Second Quarter 2020 Revenue (GlobeNewswire) - "Preliminary second quarter 2020 revenue consisted of net product sales of $124.0 million and royalty revenue of $2.7 million. Preliminary second quarter 2020 net product sales of $124.0 million increased 21% compared to the same period in 2019 due to higher net product sales of Trokendi XR and Oxtellar XR and the addition of $10.6 million of net product sales from the acquisition of the CNS portfolio of US WorldMeds, which closed on June 9, 2020."

Sales • CNS Disorders • Migraine • Pain

Past, present and future of pharmacotherapy for obesity. (PubMed, Clin Investig Arterioscler) - "...There are currently 3 drugs approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for obesity therapy (orlistat, combination of bupropion and delayed-release naltrexone and liraglutide) and two more only authorized by FDA (lorcaserin and the combination of phentermine and extended release topiramate). It is recommended to use as a second therapeutic line and its choice should be individualized taking into account multiple aspects such as expected weight loss, route of administration, safety profile and cost. Currently there are several drugs under development that act on different therapeutic targets."

Journal • Biosimilar • Obesity

Supernus announces fourth quarter and full year 2013 results (Supernus Pharmaceuticals Press Release) - “We continue to see that our products are very promotion sensitive, with increasing conversion share strongly correlated with call frequency. As a result, we plan to expand our sales force, from 110 representatives at year-end 2013, to more than 150 representatives by mid-2014….For Trokendi XR, 128.8 million lives are covered (113.5 million commercial; 15.3 million Medicaid).”

Commercial • Epilepsy

Supernus announces issuance of third US patent protecting Trokendi XR (Supernus Pharmaceuticals Press Release) - "Supernus Pharmaceuticals Inc…announced the issuance of a third patent (number 8663683) by the United States Patent and Trademark Office (USPTO) covering Trokendi XR™...The patent was issued by the USPTO on March 04 2014. It provides protection for the product with expiration that is no earlier than 2027.” 

Patent • Epilepsy