ZEMBRACE SymTouch (sumatriptan succinate) / Dr. Reddy’s, Tonix - LARVOL DELTA

Extracellular vesicle-mediated gene editing for the treatment of nonsyndromic progressive hearing loss in adult mice. (PubMed, Sci Transl Med) - "In the Myo7aWT/Sh1 mouse model of autosomal dominant progressive hearing loss, which may model MYO7A-associated DFNA11 hearing loss in humans, we demonstrated the effective delivery of RNPs by EVs into cochlear hair cells by cross-sectional and whole-mount confocal imaging. The injection of RNP-EVs via the posterior semicircular canal in 4-week-old Myo7aWT/Sh1 mice resulted in a reduction in Myo7aSh1 messenger RNA expression and evidence of hearing preservation, as measured by auditory brainstem responses, compared with untreated ears and EV only-injected mice. This study highlights the potential of μDES-produced RNP-EVs for gene editing as a treatment for progressive nonsyndromic hearing loss in patients."

Journal • Preclinical • Gene Therapies • Otorhinolaryngology

Select autosomal dominant DFNA11 deafness mutations activate Myo7A targeting in epithelial cells. (PubMed, J Cell Sci) - "Our findings reveal that Myo7A targeting is regulated by specific IQ motifs within its lever arm, and that this regulation can function at least partially independent of its tail sequence. Importantly, we demonstrate that many of the DFNA11 deafness mutations reported in patients activate Myo7A targeting, providing a potential explanation for the autosomal dominant genetics of this form of deafness."

Journal • Otorhinolaryngology

Select autosomal dominant DFNA11 deafness mutations activate Myo7A in epithelial cells. (PubMed, bioRxiv) - "Our findings reveal that Myo7A is regulated by specific IQ motifs within its lever arm, and that this regulation can function at least partially independent of its tail sequence. Importantly, we demonstrate that many of the DFNA11 deafness mutations reported in patients activate Myo7A targeting, providing a potential explanation for the autosomal dominant genetics of this form of deafness."

Journal • Otorhinolaryngology

Tonix Pharmaceuticals Announces Issuance of U.S. Patent Covering the Subcutaneous Delivery of FDA-Approved Zembrace SymTouch to Treat Migraines (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...today announced that the United States Patent and Trademark Office issued U.S. Patent No. 12,097,183 to the Company on September 24, 2024. The patent...claims use of a pre-filled autoinjector comprising a composition of Zembrace SymTouch for treating migraines via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to provide protection into 2036."

Patent • CNS Disorders • Migraine • Pain

The prevalence and clinical features of MYO7A-related hearing loss including DFNA11, DFNB2 and USH1B. (PubMed, Sci Rep) - "On the other hand, cases with autosomal recessive inheritance or Usher syndrome showed congenital or early-onset hearing loss. The visual symptoms in the Usher syndrome cases developed between age 5-15, and the condition was diagnosed at about 6-15 years of age."

Journal • Inherited Retinal Dystrophy • Ophthalmology • Otorhinolaryngology

Sumatriptan Induced Ischemic Colitis​ (ACG 2023) - "For any individual on medication for migraine experiencing abdominal symptoms, a high index of suspicion needed for sumatriptan related ischemic colitis. Figure: Sumatriptan induced Ischemic Colitis - Gross, Microscopic and Imaging pictures"

Cardiovascular • CNS Disorders • Colonic Polyps • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Inflammation • 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

Monogenic Causes of Low-Frequency Non-Syndromic Hearing Loss. (PubMed, Audiol Neurootol) - "LFNSHL is most commonly caused by pathogenic variants in the WFS1 gene, but it is also important to consider changes in other HL genes, which may result in similar audiological phenotype."

Journal • Review • Otorhinolaryngology • GSDME • TNC

Identification of novel missense mutation related with non-syndromic sensorineural deafness, DFNA11 in korean family by NGS. (PubMed, Genes Genomics) - "This study is the first to report pathogenic mutations within MYO7A gene in Korean family and our data would facilitate diagnosing the primary cause of hereditary hearing loss in Korean."

Journal • Next-generation sequencing • Otorhinolaryngology

Novel compound heterozygous synonymous and missense variants in the MYO7A gene identified by next-generation sequencing in a Chinese family with nonsyndromic hearing loss. (PubMed, J Clin Lab Anal) - "We reported a novel missense (c.5994G > T) and identified, for the first time, a novel pathogenic synonymous (c.2904G > A) variant within MYO7A in a patient with DFNB2. These findings enrich our understanding of the MYO7A variant spectrum of DFNB2 and can contribute to accurate genetic counseling and diagnosis of NSHL patients."

Biomarker • Journal • Next-generation sequencing • Inherited Retinal Dystrophy • Ophthalmology • Otorhinolaryngology

Clinical Heterogeneity Associated with MYO7A Variants Relies on Affected Domains. (PubMed, Biomedicines) - "MYO7A variants are associated with DFNA11, a subtype of ADHL...Audiological differences among individuals correspond to specific domains which contain the variants. Therefore, appropriate rehabilitation is needed, particularly for patients with late-onset familial hearing loss."

Heterogeneity • Journal • Otorhinolaryngology

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

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

Journal • CNS Disorders • Migraine • Pain

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

Auditory Outcome after Cochlear Implantation in Children with DFNB7/11 Caused by Pathogenic Variants in TMC1 Gene. (PubMed, Audiol Neurootol) - "Our results do not support the variable auditory outcome reported in the literature, which may be affected by several social and environmental factors and by the genetic background."

Clinical • Journal • Otorhinolaryngology • Pediatrics

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

Lasmiditan (Reyvow) and ubrogepant (Ubrelvy) for acute treatment of migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine

[VIRTUAL] Treatment Outcomes for Oral, Subcutaneous and Intranasal Forms of Sumatriptan: Survey Results from Migraine in America Symptoms and Treatment (MAST) Study (AHS 2020) - "The proportion of participants achieving complete and meaningful relief of pain and associated symptoms was highest for subcutaneous, intermediate for oral and lowest for intranasal triptan users. Among responders, a higher proportion of participants achieved relief within one hour with intranasal vs. subcutaneous triptans followed by oral triptans."

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

The effect of weight, body mass index, age, sex, and race on plasma concentrations of subcutaneous sumatriptan: a pooled analysis. (PubMed) - Clin Pharmacol - "Weight and BMI appear to be important covariates for sumatriptan exposure: subjects with lower values for either metric of body size have higher systemic exposure compared with subjects with higher values. Additional studies are required to determine if doses of subcutaneous sumatriptan may be adjusted based on BMI for comparable efficacy and a potentially improved tolerability profile."

Journal • Biosimilar • Migraine

The p.R206C Mutation in MYO7A Leads to Autosomal Dominant Nonsyndromic Hearing Loss. (PubMed, ORL J Otorhinolaryngol Relat Spec) - "The recurrent p.R206C variant in MYO7A is pathogenic and is likely in a mutation hot spot or due to a founder effect. Reports of such rare variants in multiple patients or families may facilitate exploitation of its pathogenicity."

Journal

Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine (clinicaltrials.gov) - P2; N=20; Completed; Sponsor: Dr. Reddy's Laboratories Limited; Recruiting ➔ Completed

Trial completion • Biosimilar • Migraine