lacosamide extended release (ADS-4101) / Supernus Pharma - LARVOL DELTA

In Vitro Enteral Feeding Tube Study for Lacosamide Extended-Release Capsules (AES 2025) - "The above study demonstrated that the entire contents inside Lacosamide ER Capsules can be adequately delivered via enteral feeding tubes through 16 Fr or above for nasogastric tubes and 18 Fr or above for gastrostomy tubes. This proposed alternative administration method via feeding tube in addition to the approved labeling preserves the correct dose and the expected safety and effectiveness of Lacosamide ER Capsules."

Preclinical • CNS Disorders • Epilepsy

In Vitro Soft Food Study for Lacosamide Extended-Release Capsules (AES 2025) - "The above in vitro soft food study demonstrated that applesauce is suitable for being used as sprinkle delivery vehicle for Lacosamide ER Capsules by opening the whole capsule and sprinkling the internal beads onto up to 15 mL of applesauce for immediate drug administration in addition to the approved labeling (Reference: FDA draft guidance, Use of Liquids and/or Soft Foods as Vehicles for Drug Administration, effective in July 2018). This alternative sprinkling oral administration option for Lacosamide ER capsules is very important for patients with swallowing difficulties as it supports medication adherence and overall treatment success."

Preclinical • CNS Disorders • Epilepsy

Neither Food nor the Use of Sprinkle Delivery Impacts the Oral Bioavailability of a Novel Extended-release Formulation of Lacosamide (AES 2024) - "Rationale: The pharmacokinetic (PK) investigation of lacosamide extended-release (XR) capsules in this study aimed to shed light on the influence of food intake and sprinkle delivery on drug absorption, a critical consideration in optimizing therapeutic outcomes. The PK parameters of lacosamide XR were compared when taken in the fasted state, fed state, and when sprinkled on applesauce. Coadministration of lacosamide XR with a high-fat meal or the use of a sprinkle administration do not affect the overall exposure of lacosamide. Lacosamide XR capsules can be taken with or without meals and can be used as a sprinkle."

CNS Disorders • Epilepsy

Lacosamide extended-release capsules are bioequivalent to lacosamide immediate-release tablets: Pharmacokinetic observations and simulations. (PubMed, Epilepsy Res) - "Once-daily lacosamide XR capsules were bioequivalent to twice-daily lacosamide IR tablets. Pharmacokinetic simulations indicated lacosamide XR and IR formulations were similarly affected by partial adherence, though once-daily dosing with lacosamide XR may offer clinical advantages, and formulations can be easily switched. These results support the use of lacosamide XR capsules as a once-daily alternative to lacosamide IR tablets."

Journal • PK/PD data • CNS Disorders • Epilepsy

Efficacy and tolerability of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed temporal lobe epilepsy: Post hoc analysis of a randomized, double-blind trial. (PubMed, Seizure) - P3 | "Lacosamide was efficacious and generally well tolerated as monotherapy in patients with TLE with efficacy outcomes comparable with CBZ-CR, and fewer patients on LCM reported any TEAEs, drug-related TEAEs, or discontinued due to TEAEs."

Clinical • Journal • Monotherapy • Retrospective data • CNS Disorders • Epilepsy

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic（PK）Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Overseas Pharmaceuticals, Ltd.

New P1 trial • CNS Disorders • Epilepsy

Adamas Announces Issuance of New Patents for GOCOVRI and ADS-4101 (Businesswire) - "Issuance of ADS-4101 patent in Japan for partial onset seizures in patients with epilepsy strengthens partnering opportunity...Adamas Pharmaceuticals...announces the issuance of two patents covering GOCOVRI® (amantadine) extended-release capsules: U.S. Patent No. 11,065,213 issued on July 20, 2021, and U.S. Patent No. 11,077,073, projected to issue on August 3, 2021....With the issuance of these two patents, Adamas’ portfolio of patents for GOCOVRI now includes 17 U.S. patents across four separate patent families that will expire from 2025 to 2038. These latest patents will be listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations, commonly known as the Orange Book."

Patent • CNS Disorders • Epilepsy • Parkinson's Disease

Adamas Reports First Quarter 2021 Financial Results (Businesswire) - "Patents issued (U.S. Patent: 10,973,783 and 10,987,324) in April 2021 covering ADS-4101, an investigational high-dose, modified release lacosamide capsule for partial onset seizures in patients with epilepsy. Efforts continue to partner or out-license this program."

Patent • CNS Disorders • Epilepsy

Adamas reports first quarter 2018 financial results (GlobeNewswire) - "Received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the clinical development plans for ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy"

FDA event • CNS Disorders • Epilepsy

Long-term safety and efficacy of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed epilepsy. (PubMed, Epilepsia) - P3 | "Long-term (median ~2 years) lacosamide monotherapy was efficacious and generally well tolerated in adults with newly diagnosed epilepsy. Seizure freedom rates were similar with lacosamide and carbamazepine-CR."

Clinical • Journal • Monotherapy • CNS Disorders • Epilepsy • Immunology

Tolerability and efficacy of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed epilepsy and concomitant psychiatric conditions: Post hoc analysis of a prospective, randomized, double-blind trial. (PubMed, Epilepsy Res) - P3; "This exploratory post hoc analysis indicated that lacosamide monotherapy was efficacious and generally well tolerated in patients with newly diagnosed epilepsy and concomitant psychiatric conditions. In this subpopulation, lacosamide showed similar efficacy and numerically better effectiveness than carbamazepine-CR."

Clinical • Journal • Monotherapy • Retrospective data