topiramate XR / Generic mfg. - LARVOL DELTA

Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old (clinicaltrials.gov) - P4 | N=132 | Recruiting | Sponsor: Upsher-Smith Laboratories | Trial completion date: Oct 2023 ➔ Sep 2026 | Trial primary completion date: Jun 2023 ➔ Sep 2026

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

The pharmacokinetics of single oral dose extended-release topiramate and adverse effects after multi-dose administration in healthy cats. (PubMed, J Vet Pharmacol Ther) - "If effective and safe, topiramate extended-release (XR) could broaden the current treatment options for feline epilepsy. While no clinically apparent adverse effects were observed, four out of eight cats developed subclinical anemia, calling into question the safety of topiramate XR with chronic administration. Further studies are necessary to better understand the potential adverse effects and overall efficacy of topiramate XR for the treatment of feline epilepsy."

Adverse events • Journal • PK/PD data • CNS Disorders • Epilepsy • Glaucoma • Hematological Disorders • Ophthalmology

Zydus launches Topiramate extended-release capsules (ExpressPharma) - "Zydus Pharma has launched Topiramate extended-release capsules. The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate extended-release capsules, USP 25 mg, 50 mg and 100 mg, a company statement notified."

Generic launch • CNS Disorders • Epilepsy

USFDA Nod To Zydus Lifesciences Migraine Drug Topiramate Extended Release (Medical Dialogues) - "Zydus Lifesciences Limited...has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (USRLD: Qudexy XR Extended-Release capsules). Topiramate Extended-Release capsule is indicated to prevent and control seizures in people with epilepsy. It may also be used to prevent migraine headaches."

ANDA • CNS Disorders • Epilepsy • Migraine • Pain

UNLIMITED: A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight (clinicaltrials.gov) - P3 | N=1855 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A.

Head-to-Head • New P3 trial • Genetic Disorders • Obesity

Usefulness of extended-release topiramate in patients with epilepsy: A two-year retention study. (PubMed, J Clin Pharm Ther) - "The favourable retention rate of TPM-XR shows that TPM-XR can be an effective treatment option for epilepsy patients, as either a monotherapy or as an adjunctive therapy. Additionally, switching AED regimen to TPM-XR from TPM-IR can be considered in selected epilepsy patients with poor adherence to TPM-IR."

Clinical • Journal • CNS Disorders • Epilepsy

Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old (clinicaltrials.gov) - P4; N=132; Recruiting; Sponsor: Upsher-Smith Laboratories; Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine

Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (PRNewswire) - "Glenmark Pharmaceuticals...has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, the generic version of Qudexy® XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher-Smith Laboratories, LLC."

ANDA • CNS Disorders • Migraine • Pain

Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old (clinicaltrials.gov) - P4; N=132; Not yet recruiting; Sponsor: Upsher-Smith Laboratories

Clinical • New P4 trial • CNS Disorders • Migraine

Migraine Patients With High-Deductible Commercial Healthcare Plans To Benefit From Upsher-Smith's Expanded Access Pathways Program (PRNewswire) - "Upsher-Smith Laboratories...announced...the Company's expanded Access Pathways® Program for free acute and preventive migraine treatments. Eligible patients who use the program's new online pharmacy option pay $0* per prescription and can receive free home delivery for each of Upsher-Smith's migraine medications including: Tosymra® (sumatriptan nasal spray) 10 mg and Zembrace® SymTouch® (sumatriptan injection) 3 mg for the acute treatment of migraine in adults and Qudexy® XR (topiramate) Extended-Release Capsules for the prevention of migraine headache in adults and adolescents."

Reimbursement • CNS Disorders • 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

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

Use of phentermine-topiramate extended release in combination with sleeve gastrectomy in patients with BMI 50 kg/m or more. (PubMed, Surg Obes Relat Dis) - "Compared with LSG alone, phen/top combined with LSG may help patients with a BMI >50 achieve greater weight loss and reach a BMI <40. Long-term, controlled trials are needed to follow up these results."

Clinical • Combination therapy • Journal • Genetic Disorders • Obesity

Upsher-Smith Offers Help To People With Migraines During National Migraine And Headache Awareness Month (PRNewswire) - "Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced its continued commitment to people who suffer from migraines....Upsher-Smith's consistent supply of self-administered medications....The Company's self-administered migraine products include Tosymra® (sumatriptan nasal spray) 10 mg and Zembrace® SymTouch® (sumatriptan) Injection 3 mg for the acute treatment of migraine in adults and Qudexy® XR (topiramate)....Eligible patients pay $0 Per Prescription for their migraine medication with the Platinum Pass® Savings Card."

Reimbursement • CNS Disorders • Migraine • Pain

Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker (clinicaltrials.gov) - P4; N=80; Recruiting; Sponsor: Mayo Clinic; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genetic Disorders • Obesity

Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker (clinicaltrials.gov) - P4; N=80; Not yet recruiting; Sponsor: Mayo Clinic

Clinical • New P4 trial • Genetic Disorders • Obesity

Upsher-Smith launches online community resource program for patients living with seizure clusters (Multivu) - “Upsher-Smith Laboratories…announced a new educational program created for patients living with seizure clusters, as well as their families and friends. The initiative—called Seizure Clusters Connect™—uses traditional and social media to offer patients and their caregivers a community for learning and support….Upsher-Smith's central nervous system (CNS) pipeline includes a number of investigational drug programs for various indications within epilepsy, including USL255, USL260, and USL261.”

eHealth • Epilepsy

Phentermine/Topiramate Extended Release as an Adjunct to Sleeve Gastrectomy in BMI≥50 kg/m2 (OBESITY WEEK 2017) - "Patients with a BMI≥50 kg/m2 treated with P/T+SG had greater percent weight loss through 12 months, even after adjustment for higher initial BMI. Additional follow up is needed to assess longer term effects of this pharmacologic and surgical co-intervention."

Clinical • Late-breaking abstract • Biosimilar

Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED) (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: Lindner Center of HOPE

New P2 trial • Biosimilar • Dyslipidemia • Obesity

Upsher-Smith research on Qudexy XR (topiramate) extended-release capsules highlighted at the 2015 American Academy of Neurology Annual Meeting (PRNewswire) - "Upsher-Smith Laboratories...presented data from a 52-week, open-label extension study (PREVAIL OLE) showing that Qudexy™ XR (topiramate) extended-release capsules offered a long-term adjunctive treatment option with a favorable tolerability profile for a high proportion of patients with refractory partial-onset seizures (POS). In a separate presentation, researchers also reported that when Qudexy™ XR capsules were opened and sprinkled onto soft food, they remained bioequivalent to intact capsules, making them a useful alternative for patients with swallowing difficulties. These results were presented at the American Academy of Neurology's (AAN) Annual Meeting in Washington, DC on April 18-25, 2015....Data from a study evaluating an alternative administration method for Qudexy™ XR was also presented."

Clinical data • Epilepsy

Upsher-Smith laboratories adds Zembrace SymTouch (sumatriptan) injection to its access pathways Platinum Pass Savings Program (PRNewswire) - "Upsher-Smith Laboratories...today announced that it has added Zembrace® SymTouch® (sumatriptan) Injection 3 mg to its Access Pathways® Platinum Pass® Program – a savings and support program where eligible patients pay $0 per prescription....Zembrace SymTouch joins Qudexy® XR (topiramate) Extended-Release Capsules and Tosymra™ (sumatriptan) Nasal Spray as part of Upsher-Smith's portfolio of medications supported by the program."

Reimbursement

Effects of Education and Experience on Primary Care Providers' Perspectives of Obesity Treatments during a Pragmatic Trial. (PubMed, Obesity (Silver Spring)) - "PCPs initially overvalued exercise and undervalued weight-loss medications. PCPs exposed to education and experience gave higher comfort and effectiveness ratings to weight-loss medications."

Clinical • Journal

Upsher-Smith unveils educational resources and support tools for migraine patients (PRNewswire) - "Upsher-Smith Laboratories...today announced the launch of its newly redesigned website for Qudexy® XR (topiramate) Extended-Release Capsules. The enhanced website offers support tools and educational resources for those living with migraine and seeking information about preventative treatment."

eHealth

"Glenmark Pharma: Gets @US_FDA Tentative Nod For Generic Of Qudexy XR" (@BTVI)