lamotrigine extended release / Generic mfg. - LARVOL DELTA

Rutgers study challenges FDA warning on antiseizure drug (News-Medical) - "Rutgers Health researchers found that lamotrigine, a widely prescribed antiseizure medication, to be safe in older adults with epilepsy, contrary to a safety warning by the Food and Drug Administration (FDA)...In 2020, the FDA placed a safety warning label on lamotrigine based on reports the drug could increase the risk of heart conditions...Researchers found no increased risk for heart rhythm problems or sudden cardiac arrest among older adults taking lamotrigine compared to those using the other commonly prescribed antiseizure drug, levetiracetam. Study findings were consistent across a range of subgroups, including age, gender, race and those with histories of heart conditions."

Clinical data • CNS Disorders • Epilepsy

FDA endorses 10 more drug products for VAT exemption (Manila Bulletin) - "The newly endorsed VAT-exempt drugs are as follows: High cholesterol: Atorvastatin (as calcium) + Fenobribrate 20 mg/160 mg; Cancer: Tegafur + Gimeracil + Oteracil Potassium 20 mg/5.8 mg/19.6 mg and Tegafur + Gimeracil + Oteracil Potassium 25 mg/7.25 mg/24.5 mg; Diabetes: Metformin Hydrochloride + Teneligliptin (as hydrobromide hydrate) 1 g/20 mg and Metformin Hydrochloride + Teneligliptin (as hydrobromide hydrate) 500 mg/20 mg; Hypertension: Metoprolol tartrate + Ivabradine (as hydrochloride) 50 mg/5 mg and Metoprolol tartrate + Ivabradine (as hydrochloride) 25 mg/5 mg; Hypertension: Metoprolol tartrate + Ivabradine (as hydrochloride) 50 mg/5 mg and Metoprolol tartrate + Ivabradine (as hydrochloride) 25 mg/5 mg; Mental illness: Lamotrigine 5 mg (dispersible/chewable tablet), Lamotrigine 25 mg (oral dispersible tablet), and Lamotrigine 25 mg (tablet)"

Commercial • FDA event • Breast Cancer • CNS Disorders • Colorectal Cancer • Diabetes • Dyslipidemia • Gastric Cancer • Hypertension • Non Small Cell Lung Cancer • Prostate Cancer • Renal Cell Carcinoma

Quantitative determination of related substances for Lamotrigine extended release tablet by RP-HPLC. (PubMed, Heliyon) - "Lamotrigine extended release tablet dosage form LAMICTAL XR used as an anticonvulsant in the treatment of generalized tonic clonic, absence seizures and partial seizures...Accuracy performed at LOQ to 250% level and recovery was found to be in the range of 95% to 105%. Therefore the developed related substances method provides a safe, easy and reproducible for the stability studies and QC release testing for the estimation of related substances."

Journal • Absence Seizure Disorder • Cerebral Hemorrhage • CNS Disorders • Epilepsy

Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study. (PubMed, Epilepsia) - "The generic lamotrigine ER tablet product demonstrates BE to the brand product in fully replicated BE study design with healthy subjects, supporting the adequacy of two-way crossover study design to demonstrate BE and generic-brand substitution of lamotrigine ER products."

Journal • CNS Disorders • Epilepsy

Lamotrigine and Bupropion for Meniere's Disease (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Dent Neuroscience Research Center

New P2 trial • Otorhinolaryngology • Vertigo

Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease (EIN News) - "An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine)....FDA first added information about this risk to the lamotrigine prescribing information and Medication Guides in October 2020, which has been updated."

Adverse events • FDA event • CNS Disorders • Epilepsy

Pharmac knew of epilepsy drug change risks within some patients, but went ahead with switch (NZ Herald) - "Pharmac knew there were clinical reasons some epilepsy patients would not tolerate a change to their medicines. But the drug buying agency went ahead with a switch that forced more than 10,000 people to change brands of the anti-epileptic drug lamotrigine anyway. That admission was contained in evidence presented by Pharmac today at the Chief Coroner's Inquest into whether the brand switch had any role in the deaths of six people...She said that was why Pharmac's agreement to allow the generic drug Logem to be the sole form of publicly funded lamotrigine..."

Adverse events • Reimbursement • CNS Disorders • Epilepsy

Pharmacological Treatment of Bipolar Depression: What are the Current and Emerging Options? (Dovepress) - "More recently, evidence for certain atypical antipsychotics, such as lurasidone and cariprazine, has demonstrated that it may be possible to effectively manage bipolar depression without unduly compromising patients’ long-term physical health. Furthermore...emerging evidence for several novel therapeutic targets, including the glutamatergic system and inflammatory processes, indicates the potential for alternative pharmacological treatment approaches for bipolar depression in the future."

Clinical • Review • Bipolar Disorder • CNS Disorders • Depression

Production andevaluation of a lamotrigine extended release tablet based on a controlled-porosity osmotic pump system. (PubMed, Pharmazie) - "The lamotrigine extended release tablets based on the CPOP system showed ideal reproducibility and stability. The developed system has the ability to be an alternative production method for Lamictal XR®, which could circumvent the laser drill technology and promote the osmotic pump generalization."

Journal • Biosimilar

OWP Pharmaceuticals Announces a Second IND Approval and Patent Application: The First-Ever Liquid Oral Suspension Formulation of Lamotrigine for the Treatment of Epilepsy and Bipolar Disorder (GlobeNewswire, OWP Pharmaceuticals) - "OWP Pharmaceuticals...announced today that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), and has submitted for U.S. patent protection, for the first-ever liquid formulation of lamotrigine."

Clinical • Commercial • Patent • Regulatory