Chronic pain

Scilex Holding Company Announces Launching of Co-Pay Programs for Both ZTlido® and ELYXYB® for Commercially Insured Patients and the addition of ELYXYB® to a Multi-State Medicaid Pharmaceutical Purchasing Group to Its Purchasing Pool

Retrieved on: 
Tuesday, April 9, 2024

Additionally, on April 1, 2024, a multi-state Medicaid pharmaceutical purchasing group added ELYXYB® to its purchasing pool to make it eligible for thirteen States’ Medicaid programs.

Key Points: 
  • Additionally, on April 1, 2024, a multi-state Medicaid pharmaceutical purchasing group added ELYXYB® to its purchasing pool to make it eligible for thirteen States’ Medicaid programs.
  • Scilex believes that high deductibles and co-pay programs should not prevent patients from receiving the medications they need.
  • Scilex co-pay programs are designed to help patients reduce their co-pay and out-of-pocket costs for their medications.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com
    For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com .

Vivos Therapeutics’ Flagship CARE Oral Medical Devices Receive Full Approval for Medicare Reimbursement

Retrieved on: 
Tuesday, April 9, 2024

Effective immediately, this milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare.

Key Points: 
  • Effective immediately, this milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare.
  • “Prior to these latest developments, moderate to severe OSA patients on Medicare were relegated almost entirely to a lifetime of some form of CPAP—something most patients find undesirable.
  • Our CARE oral medical devices, on the other hand, can significantly improve and even resolve OSA in about 12 months, with no further intervention required in most cases,” said Kirk Huntsman, Vivos Chairman and Chief Executive Officer.
  • “We are very pleased the Centers for Medicare and Medicaid Services (CMS) recognizes and validates the benefits our FDA cleared devices can have on the lives of patients diagnosed with OSA.

IntelGenx Updates Status of Buprenorphine Buccal Film ANDA

Retrieved on: 
Friday, April 5, 2024

SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

Key Points: 
  • SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.
  • The CRL includes a request for additional Pharmaceutical Quality information.
  • Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.
  • Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.

Tilray Medical Announces New Scientific Publication on Age-Related Patterns of Medical Cannabis Use

Retrieved on: 
Wednesday, April 3, 2024

NEW YORK, April 03, 2024 (GLOBE NEWSWIRE) -- Tilray Medical, a division of Tilray Brands, Inc. ("Tilray") (Nasdaq: TLRY; TSX: TLRY) and a global leader in medical cannabis, empowering the therapeutic alliance between patients and healthcare practitioners to make informed individualized health decisions, transforming healthcare, today announced a new Tilray led scientific publication, Age-related Patterns of medical Cannabis Use: A Survey of Authorized Patients in Canada. The new study was derived from the Canadian Cannabis Patient Survey (CCPS) 2021, comprised of 2,697 patients and focused primarily on older patients with a mean age of 54.3. This study presents to the medical and scientific community the consumption trends observed in patients and the self-reported impacts from medical cannabis in alleviating the patients’ primary symptoms.

Key Points: 
  • Tilray Led Study Shows Chronic Pain, Arthritis, Anxiety, and Insomnia as Primary Illnesses and Symptoms for Medical Cannabis Use
    NEW YORK, April 03, 2024 (GLOBE NEWSWIRE) -- Tilray Medical, a division of Tilray Brands, Inc. ("Tilray") (Nasdaq: TLRY; TSX: TLRY) and a global leader in medical cannabis, empowering the therapeutic alliance between patients and healthcare practitioners to make informed individualized health decisions, transforming healthcare, today announced a new Tilray led scientific publication, Age-related Patterns of medical Cannabis Use: A Survey of Authorized Patients in Canada .
  • This study presents to the medical and scientific community the consumption trends observed in patients and the self-reported impacts from medical cannabis in alleviating the patients’ primary symptoms.
  • The Age-related Patterns of Medical Cannabis Use study finds that older patients comprise a growing subset of medical cannabis patients.
  • José Tempero, Tilray’s Medical Director, said, "Our role in this initiative exemplifies our commitment to medical research, leading us one step closer to unlocking the full therapeutic potential of medical cannabis."

Trevena Reports Fourth Quarter 2023 Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024

CHESTERBROOK, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter ended December 31, 2023 and provided an overview of its recent operational highlights.

Key Points: 
  • Given performance to date, we are reducing commercial support and reviewing alternatives for OLINVYK to preserve capital,” said Carrie Bourdow, President and CEO of Trevena.
  • OLINVYK will remain available for purchase by customers, who can continue to order the product through their normal channels.
  • In a review of safety and tolerability across both studies, TRV045 was well tolerated with results generally consistent with prior first-in-human studies.
  • For the fourth quarter of 2023, the Company reported a net loss attributable to common stockholders of $16.5 million, or $1.06 per share, compared to $7.0 million, or $0.73 per share in the fourth quarter of 2022.

Scilex Holding Company Announces that the U.S. Bankruptcy Court has Extended the Lockup Period on Shares of Scilex Stock Previously Distributed by Sorrento to its Stockholders as a Dividend

Retrieved on: 
Wednesday, March 27, 2024

Such lock-up period was previously set to expire on March 31, 2024.

Key Points: 
  • Such lock-up period was previously set to expire on March 31, 2024.
  • The Court did not make any determination regarding the merits of the Stock Clawback Claims.
  • Accordingly, any shares of the Dividend Stock (including any such shares held by brokerage firms) may not be sold, transferred or otherwise disposed of and the holders of Dividend Stock would be prohibited from causing or encouraging any third party to do the same.
  • The foregoing extension shall apply only to the Dividend Stock and does not apply to any other outstanding securities of Scilex.

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

Retrieved on: 
Tuesday, March 26, 2024

FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1

Key Points: 
  • The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads.
  • “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day.
  • To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here.
  • Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

TMS Health and Wellness Introduces Cutting-Edge Brain Scanning For Enhanced TMS Therapy Effectiveness

Retrieved on: 
Monday, April 8, 2024

COSTA MESA, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- In a significant advancement for treating anxiety, depression, and other mental health conditions, TMS Health and Wellness proudly announces the integration of comprehensive brain scanning technology into its Transcranial Magnetic Stimulation (TMS) Therapy protocols. This pioneering approach, leveraging Full Brain Scans and Functional MRI (fMRI) is set to revolutionize treatment customization, potentially elevating TMS Therapy's effectiveness to an unprecedented 90%.

Key Points: 
  • This pioneering approach, leveraging Full Brain Scans and Functional MRI (fMRI) is set to revolutionize treatment customization, potentially elevating TMS Therapy's effectiveness to an unprecedented 90%.
  • By utilizing detailed brain imaging to map and understand each patient's unique neural patterns, TMS Health and Wellness can customize the application of TMS Therapy with greater precision than ever before.
  • The clinic's expanded services now include:
    With the introduction of brain scanning technology, TMS Health and Wellness reinforces its dedication to pioneering in the mental health space and its mission of treating the "whole person."
  • TMS Therapy enhanced with Full Brain Scans and Functional MRI is available now.

BioElectronics Corporation Announces the Publication of a Canine Arthritis Study

Retrieved on: 
Monday, March 25, 2024

Forty-nine animals completed the study. No negative side effects were reported. Average subjective discomfort scores for the treatment group (N=26) were reduced from 4.26 to 2.31 (45%) compared to no improvement in the placebo group (N=23) over the study period. Average PROM scores increased by 5.51 (4.59--6.23) degrees relative to the placebo group. Ninety-six percent of the treatment group showed either increased PROM or improved behavioral changes or both compared to 4% for the placebo group. Most changes occurred within the first 8 days of treatment.

Key Points: 
  • The study was published online by Veterinary Medicine & Science, and can be viewed here: https://doi.org/10.1002/vms3.1408
    A randomized, blinded, placebo-controlled 14-day study of 60 dogs having prior veterinary-diagnosis OA in at least one limb joint.
  • BioElectronics’ Model 088 device was secured near the cervical region of the dog’s spine.
  • Osteoarthritis is the most common type of arthritis in dogs and is the most common source of chronic pain in older dogs.
  • Armed with these published results, BioElectronics Corporation will pursue appropriately qualified distribution partners to market and sell its unique pulsed shortwave device into the veterinary medicine market.

Treace Celebrates 100,000 Lapiplasty® 3D Bunion Correction® Patient Milestone

Retrieved on: 
Monday, March 25, 2024

PONTE VEDRA, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced that 100,000 patients have been treated with its patented Lapiplasty® 3D Bunion Correction® System.1 This milestone coincides with the first-ever National Bunion Day in the United States, which is being sponsored by Treace on April 16, 2024, and the launch of its new patient education and brand awareness campaign.

Key Points: 
  • “Achieving this important milestone is a testament to the tireless efforts of our team members and the trust of our surgeon customers and patients, all of whom have made our journey possible,” said John T. Treace, CEO and Founder of Treace.
  • “Since our initial surgical cases in 2015, Treace has been committed to educating people about surgical options that can provide lasting relief from bunion pain through our innovative procedures that are designed to minimize recovery time, reduce recurrence rates, and improve patient outcomes.
  • Today the Company also unveiled its latest campaign to continue to drive patient education and awareness of its Lapiplasty® Procedure.
  • Treace will premiere the “Future You” commercial on the finale of “The Bachelor” TV show on March 25, 2024 at 8:00 p.m. Eastern Time on the ABC network.