Tosymra (sumatriptan nasal spray) / Dr. Reddy’s, Neurelis, Tonix - LARVOL DELTA

Tonix Pharmaceuticals Announces Issuance of U.S. Patent by the United States Patent and Trademark Office Covering the Intranasal Delivery of FDA-Approved Tosymra to Treat Migraines (Yahoo Finance) - "Tonix Pharmaceuticals Holding Corp...today announced that the United States Patent and Trademark Office issued U.S. Patent No. 12,090,139 to the Company on September, 17, 2024. The patent, entitled 'Formulations Comprising Triptan Compounds', claims a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for Tosymra. This patent, excluding possible patent term extensions, is expected to expire in 2030." "

Patent • CNS Disorders • Migraine • Pain

Efficacy and safety of intranasal agents for the acute treatment of migraine: a systematic review and network meta-analysis. (PubMed, J Headache Pain) - "Compared with other new intranasal-specific therapies in treating migraine attacks, zolmitriptan nasal spray 5 mg was the most effective agent for pain freedom at 2 h. Zavegepant nasal spray 10 mg had the fewest adverse side effects."

Journal • Retrospective data • Review • CNS Disorders • Migraine • Pain

Tonix Pharmaceuticals Announces Commitment to Supply Tosymra (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased Demand Following GSK’s Planned Discontinuation of Imitrex (sumatriptan) Nasal Spray After January 2024 (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...announced that it is committed to meeting potential increased demand for Tosymra^® (sumatriptan) nasal spray 10 mg after GlaxoSmithKline’s (GSK) planned discontinuation of Imitrex (sumatriptan) nasal spray 5 mg and 20 mg products after January, 2024....On August 8, 2023, GSK informed the U.S. Food and Drug Administration (FDA) of its plan to discontinue Imitrex nasal spray 5 mg and 20 mg doses after January 31, 2024....Tonix is preparing for potential increased demand for Tosymra (sumatriptan nasal spray) 10 mg to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg."

Commercial • Discontinued • CNS Disorders • Migraine • Pain

Tonix Pharmaceuticals Completes Acquisition of Two FDA-Approved, Marketed Migraine Products (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...today announced it has completed the acquisition of two currently-marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg....As previously announced, these products collectively generated product sales of approximately $23 million for the full year 2022."

M&A • Sales • CNS Disorders • Migraine • Pain

UPSHER-SMITH DIVESTS TWO MIGRAINE PRODUCTS (PRNewswire) - "Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has entered into a definitive agreement under which New Jersey-based Tonix Pharmaceuticals Holding Corp. (Tonix Pharmaceuticals) and its wholly owned subsidiary Tonix Medicines, Inc. (Tonix Medicines) have acquired Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. As part of the transaction, Upsher-Smith will support the transition of the products by providing certain commercial operations, regulatory and other services to Tonix Medicines for up to nine months after closing. The closing is expected to take place on June 30, 2023....Under the terms of the agreement, Tonix Medicines will make an upfront payment to Upsher-Smith at closing, and an additional payment in March 2024, or upon earlier conclusion of the transition period. Tonix will also acquire certain product-related inventories at closing."

M&A • CNS Disorders • Migraine • Pain

Drugs for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Comparison table: Triptans. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Upsher-Smith Partners With Cove To Expand Access To Its Migraine Medication Tosymra (Sumatriptan Nasal Spray) 10 mg (PRNewswire) - "Upsher-Smith Laboratories, LLC...announced its partnership with Cove, a telemedicine company focused entirely on migraine. Upsher-Smith's non-oral acute migraine medication, Tosymra® (sumatriptan nasal spray) 10 mg, will now be offered through Cove's telemedicine platform as a treatment option for patients, particularly those who may not have easy access to specialized migraine care. Tosymra® is indicated for the acute treatment of migraine with or without aura in adults."

Licensing / partnership • CNS Disorders • Migraine • Pain

Acute Treatment of Migraine: What has Changed in Pharmacotherapies? (PubMed, Neurol India) - "Two new formulations of sumatriptan, DFN-11 (3 mg doses of subcutaneous sumatriptan) and DFN-02 (a nasal spray of sumatriptan 10 mg and a permeation-enhancing excipient), have been developed, and both of them showed a fast-onset action with efficacy for acute treatment of migraine with fewer adverse events...Only lasmiditan has progressed to phase III clinical trials and was finally approved by the Food and Drug Administration (FDA) for acute migraine treatment...Ubrogepant and rimegepant demonstrated statistically significant efficacy, and both were recently approved by the FDA. These 5-HT receptor agonists and CGRP receptor antagonists did not cause vasoconstriction, offering advantages over the current mainstay of specific acute migraine treatment. Overall, these new agents have expanded the available acute therapies for migraine treatment and will likely change the strategy with which we treat patients with migraine in the future."

Journal • Review • 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

Upsher-Smith Reimagines Prescriber Education With Launch Of Migraine PeerConnect (PRNewswire) - "Upsher-Smith Laboratories...today announced that as part of its ongoing effort to reimagine prescriber education during the COVID-19 pandemic, it has launched a new and innovative peer-to-peer product education program entitled Migraine PeerConnect. The program, which includes a series of videos...to maintain a virtual relationship with prescribers by providing medically relevant and engaging content about migraine treatment options including fast-acting Tosymra® (sumatriptan nasal spray) 10 mg, an acute treatment for migraine with or without aura in adults."

Educational event • CNS Disorders • Migraine • Pain

Upsher-Smith Supports The American Headache Society's Virtual 2020 Scottsdale Headache Symposium As Gold Level Sponsor (PRNewswire) - "Upsher-Smith Laboratories, LLC...today announced that it will be attending the American Headache Society's 2020 Scottsdale Headache Symposium® as a Gold Level Sponsor. Due to the COVID-19 pandemic, the meeting will be held virtually and launch on November 21, 2020 at 9:00 a.m. PST. Meeting attendees are encouraged to visit Upsher-Smith's virtual booth to learn more about its migraine products including Tosymra® (sumatriptan nasal spray) 10 mg and Zembrace® SymTouch® (sumatriptan injection) 3 mg, both for the acute treatment of migraine with or without aura in adults."

Live event • CNS Disorders • Migraine • Pain

DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment. (PubMed, CNS Drugs) - P2 | "DFN-02 was superior to placebo for the relief of migraine-related functional disability, and provided greater satisfaction than placebo or subjects' usual acute treatment."

Clinical • Journal • CNS Disorders • Migraine • Pain

[VIRTUAL] Incidence of Teaes by Dose in a Multicenter, Open-label, Long-term, Safety Study of DFN-02 (Tosymra™, Nasal Spray of Sumatriptan 10 Mg Plus Permeation Enhancer Intravail®) for Acute Migraine Treatment (AHS 2020) - "DFN-02 was well tolerated in this long-term safety study with patients treating multiple migraine headaches acutely; most patients who experienced TEAEs at the administration site had mild events, and no patients withdrew from the study due to application site pain or application site reaction."

Clinical • CNS Disorders • Migraine • Pain

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

DFN-02 Open Label Safety Study in Patients With Acute Migraine (clinicaltrials.gov) - P3; N=150; Active, not recruiting; Sponsor: Dr. Reddy's Laboratories Limited; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Migraine

Aegis Therapeutics announces use of Intravail® in a Positive Phase 2 Study of DFN-02 for Acute Migraine (GlobeNewswire) - "Dr. Reddy's Laboratories in collaboration with Promius Pharma, LLC (a wholly owned subsidiary of DRL) is developing DFN-02, a novel intranasal migraine treatment using Intravail for the acute treatment of adults with migraine with or without aura.  Promius Pharma will market the drug product once approved."

Licensing / partnership • Migraine

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

Dr. Reddy’s Q2 & H1 FY20 financial results (Businesswire) - "Proprietary Products (PP); Revenues from PP at Rs. 7.4 billion. It includes Rs. 7.2 billion towards license fee for selling US and select territory rights for two of our Neurology brands ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRA^TM (sumatriptan nasal spray) 10 mg, to Upsher-Smith Laboratories, LLC. The costs associated with this transaction are Rs. 328 million."

Commercial

Upsher-Smith Laboratories launches Tosymra (sumatriptan) nasal spray for the acute treatment of migraine in adults (PRNewswire) - "Upsher-Smith Laboratories...today announced the launch of Tosymra™ (sumatriptan) Nasal Spray, 10 mg for the acute treatment of migraine with or without aura in adults....Tosymra is supported by Upsher-Smith's Access Pathways® Program, which provides savings and support services for patients. The Platinum Pass® savings card enables commercially insured patients to pay as little as $0 per prescription."

Launch • Reimbursement

Dr. Reddy’s Laboratories announces closure of the transaction to divest Zembrace Symtouch and Tosymra to Upsher-Smith Laboratories, LLC (Businesswire) - "Dr. Reddy’s Laboratories Limited...announces the closure of the transaction with Upsher-Smith Laboratories, LLC (Upsher-Smith), pursuant to the satisfactory completion of all customary closing conditions including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended. Under the agreement Dr. Reddy’s sold its US and select territory rights for ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRA™ (sumatriptan nasal spray) 10 mg, which were commercialized through its wholly owned subsidiary, Promius Pharma, LLC."

Licensing / partnership

Upsher-Smith Laboratories completes acquisition of two treatments for acute migraine in adults (PRNewswire) - "Upsher-Smith Laboratories...today announced that it has completed the acquisition of Tosymra™ (sumatriptan) Nasal Spray, 10 mg, and Zembrace® SymTouch® (sumatriptan) Injection 3 mg from Dr. Reddy's Laboratories Limited. The products were previously commercialized through Dr. Reddy's wholly owned subsidiary, Promius Pharma LLC. Both medications are indicated for the acute treatment of migraine with or without aura in adults."

Licensing / partnership

Evaluation of the Number of Migraine Headache Days and Hours in Subjects Using DFN‐02 for Acute Treatment in a Long Term Open‐label safety study (AHS 2019) - "Background DFN-02 (Tosymra™) is a novel intranasal spray formulation of sumatriptan 10 mg and a permeation enhancer approved by the FDA for the acute treatment of migraine with or without aura in adults...Conclusion In subjects using DFN-02 to treat their migraine headaches acutely during a 6 months study, there was a statistically significant and clinically meaningful reduction in the number of both migraine headache days and hours from month 1 to month 6 during the study, supporting the importance of effective acute treatment in the management of migraine. Additional prospective studies are required to evaluate if DFN-02 can play a role in slowing the progression of migraine and prevent the development of chronic migraine."

Clinical • Late-breaking abstract

Dysgeusia Rates in a Multicenter, Open‐Label, Long‐Term, Safety Study of DFN‐02, an Intranasal Spray of Sumatriptan 10 mg Plus Permeation Enhancer DDM, for Acute Treatment of Migraine (AHS 2019) - "Conclusion DFN-02 was well tolerated, also from the dysgeusia aspect, in a long-term safety study with subjects treating multiple migraine headaches acutely; there were low rates of dysgeusia per dose and low discontinuation rates with no subjects withdrawing due to dysgeusia. The low rates of dysgeusia observed in the study can probably be attributed to Intravail™ effectively enhancing sumatriptan's nasal absorption."

Clinical • Late-breaking abstract

Triptan‐Related Adverse Events in a Multicenter, Open‐Label, Long‐Term, Safety Study of DFN‐02, an Intranasal Spray of Sumatriptan 10 mg plus Permeation Enhancer DDM, for the Acute Treatment of Migraine (AHS 2019) - "Conclusion Overall, DFN-02 was well tolerated in the long-term safety study in which subjects were treating multiple migraine headaches for up to 6 months. There were low rates of triptan-related TEAEs reported and the discontinuation rate due to triptan-related TEAEs was equally low as well."

Adverse events • Clinical • Late-breaking abstract