Oxtellar XR (oxcarbazepine extended release) / Supernus Pharma - LARVOL DELTA

Supernus Announces Third Quarter 2022 Financial Results (BioSpace) - "For the three months ended September 30, 2022, net product sales were $172.7 million, a 19% increase over net product sales of $145.5 million for the same period in 2021. For the nine months ended September 30, 2022, net product sales were $485.6 million, an 18% increase over net product sales of $412.5 million for the same period in 2021. The increases in both periods were primarily due to net product sales of GOCOVRI and growth in net product sales of Qelbree and Oxtellar XR."

Commercial • CNS Disorders • Epilepsy

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Supernus Announces Second Quarter 2022 Financial Results (Streetinsider.com) - "SPN-817 – A novel product candidate for the treatment of epilepsy; An open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is expected to start in the fourth quarter of 2022....For the three months ended June 30, 2022, net product sales were $165.5 million, a 19% increase over $138.6 million for the same period in 2021. For the six months ended June 30, 2022, net product sales were $312.9 million, a 17% increase over $267.0 million for the same period in 2021. The increases in both periods were primarily due to net product sales of GOCOVRI and growth in net product sales of Qelbree and Oxtellar XR."

Commercial • New P2 trial • CNS Disorders • Epilepsy

Supernus Pharmaceuticals Inc (SUPN) Q1 2021 Earnings Call Transcript (The Motley Fool) - "Compared to last year...net sales of Oxtellar XR grew by 14%...Net product sales for the first quarter of 2021 included $99.2 million from Trokendi XR and Oxtellar XR, reflecting 7% growth versus the first quarter of 2020."

Sales • CNS Disorders • Epilepsy

Predicted Efficacy of Once-Daily Extended-Release Oxcarbazepine (Oxtellar XR) Monotherapy in Adults and Children with Partial-Onset Seizures: Exposure-Response Modeling and Simulation. (PubMed, Clin Pharmacol) - "This model-based analysis predicted comparable efficacy for OXC-XR qd vs OXC-IR bid at MHD C concentrations corresponding to 1200 and 2400 mg/day as monotherapy or adjunctive therapy. Based on this analysis, the US Food & Drug Administration approved OXC-XR for use as monotherapy in adults and children ≥6 years of age with POS."

Clinical • Journal • Monotherapy • CNS Disorders • Epilepsy

Supernus Sues Apotex for Infringement of Oxtellar XR Patents (GlobeNewswire) - "Supernus Pharmaceuticals, Inc....announced that earlier today it sued generic drug maker Apotex Inc. and Apotex Corp...for infringement of nine patents covering its antiepileptic drug Oxtellar XR®. Supernus's United States Patent Nos. 7,722,898, 7,910,131, 8,617,600, 8,821,930, 9,119,791, 9,351,975, 9,370,525, 9,855,278, and 10,220,042 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. These nine patents do not expire until April 13, 2027"

Corporate lawsuit • Patent • CNS Disorders • Epilepsy

Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR® (GlobeNewswire, Supernus Pharmaceuticals, Inc.) - "Supernus Pharmaceuticals...today announced that on May 14, 2020 the Company received a Paragraph IV Notice Letter from Apotex Inc and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights (IPR) relating to Oxtellar XR."

Clinical • Regulatory • CNS Disorders

Supernus announces paragraph IV ANDA filing for Oxtellar XR (GlobeNewswire) - "Supernus Pharmaceuticals...announced that on May 14, 2020 the Company received a Paragraph IV Notice Letter from Apotex Inc. and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets....Oxtellar XR is currently protected by nine patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2027."

ANDA • CNS Disorders

Supernus announces first quarter 2020 financial results (GlobeNewswire) - "First quarter 2020 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 203,404, a 2% increase over first quarter 2019....Supply of Trokendi XR and Oxtellar XR has not been impacted by COVID-19. The Company has adequate inventory on hand for both products to continue to be available to patients."

Commercial • CNS Disorders • Migraine • Pain

Predicted Efficacy of QD Extended-Release Oxcarbazepine (Oxtellar XR®) Monotherapy in Adults and Children with Partial-Onset Seizures: Exposure-Response Modeling and Simulation (AES 2019) - "Exposure-response modeling and simulations comparing QD Oxtellar XR (extended-release oxcarbazepine, Supernus Pharmaceuticals, Inc.) and BID Trileptal (immediate-release carbamazepine, Novartis) were performed to support the extrapolation of adjunctive Oxtellar XR efficacy in adults to monotherapy in adults and children. In children, predicted mean %SFR ranged from -54.3% to -58.1% (QD Oxtellar XR) and ‑32.5% to -70.4% (BID Trileptal). Conclustions A model-based analysis predicted comparable efficacy for QD Oxtellar XR vs. BID Trileptal, supporting the use of QD Oxtellar XR as monotherapy in adults and children >=6 years of age with partial-onset seizures."

Clinical • Monotherapy

Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia (clinicaltrials.gov) - P4; N=0; Withdrawn; Sponsor: University of Colorado, Denver; N=30 ➔ 0; Trial completion date: Dec 2019 ➔ Dec 2018; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Nov 2019 ➔ Dec 2018

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal

Supernus Announces Second Quarter 2019 Financial Results (GlobeNewswire, Supernus Pharmaceuticals, Inc.) - Submission of New Drug Application for SPN-812 on track for the second half of 2019. Second quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 209,066, a 7.4% increase over the second quarter of 2018. Prescriptions Q2 2019 Q2 2018 Change % Trokendi XR168,682 158,568 6.4%Oxtellar XR40,384 36,066 12.0%Total209,066 194,634 7.4% Source: IQVIA. “Following the abnormally large seasonal decline we experienced in the first quarter of 2019, reflecting the impact of high deductible managed care programs, prescription growth for Trokendi XR has been hindered by a moderate contraction in the overall topiramate market.

Commercial • Regulatory

Supernus Announces First Quarter 2019 Financial Results (GlobeNewswire, Supernus Pharmaceuticals, Inc.) - Prescription growth of 11% in 2019, for both Trokendi XR and Oxtellar XR, as compared to 2018. First quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 199,520, an 11.0% increase over the first quarter of 2018.

Commercial

Efficacy Extrapolation Analyses of Extended-Release Oxcarbazepine (Oxtellar XR®) as Once-Daily Monotherapy in Adults and Children with Partial-Onset Seizures (AAN 2019) - "The model-based analysis demonstrated that the predicted efficacy of QD Oxtellar XR as adjunctive therapy in adults support the use of QD Oxtellar XR as monotherapy in adults and children ≥6 years of age with POS. ."

Clinical • Monotherapy