Post hoc analysis

Endo Announces Five Presentations at the Sexual Medicine Society of North America (SMSNA) Annual Meeting

Retrieved on: 
Thursday, November 16, 2023

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.

Key Points: 
  • DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.
  • "The relatively common condition of Peyronie's disease—estimated to affect 1 in 10 men in the U.S.—remains under-studied and is often misunderstood," said Dr. Jesse Mills, urologist and presenter of the data analysis poster.
  • "Efforts like the post hoc analysis of XIAFLEX® Phase 3 data and the new landmark registry aim to advance medical knowledge of PD and support patient outcomes."
  • The five new Endo-sponsored and Endo-supported presentations are below:
    Peyronie's Disease Patients with Penile Pain at Baseline Treated with Collagenase Clostridium Histolyticum: A Post Hoc Analysis
    Outcomes of Collagenase Clostridium Histolyticum in Men with Ventral Curvatures: An Updated Series
    Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
    Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 1 Year Outcomes

Endo Announces Five Presentations at the Sexual Medicine Society of North America (SMSNA) Annual Meeting

Retrieved on: 
Thursday, November 16, 2023

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.

Key Points: 
  • DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.
  • "The relatively common condition of Peyronie's disease—estimated to affect 1 in 10 men in the U.S.—remains under-studied and is often misunderstood," said Dr. Jesse Mills, urologist and presenter of the data analysis poster.
  • "Efforts like the post hoc analysis of XIAFLEX® Phase 3 data and the new landmark registry aim to advance medical knowledge of PD and support patient outcomes."
  • The five new Endo-sponsored and Endo-supported presentations are below:
    Peyronie's Disease Patients with Penile Pain at Baseline Treated with Collagenase Clostridium Histolyticum: A Post Hoc Analysis
    Outcomes of Collagenase Clostridium Histolyticum in Men with Ventral Curvatures: An Updated Series
    Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
    Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 1 Year Outcomes

Ardelyx Shares Positive Data on Symptom Response During Treatment With IBSRELA® (tenapanor) for IBS-C and hosts IBS-C Product Theater at ACG 2023

Retrieved on: 
Monday, October 23, 2023

“Physicians and other professionals attending ACG 2023 work with IBS-C patients every day and know all too well how challenging this condition can be.

Key Points: 
  • “Physicians and other professionals attending ACG 2023 work with IBS-C patients every day and know all too well how challenging this condition can be.
  • “While a significant proportion of patients will have an early positive response to IBSRELA treatment, patient response rates increase with continued therapy.
  • The researchers concluded that these patients experience a relatively quick onset of symptom relief under tenapanor treatment and that weekly response rates continued to increase with treatment duration.
  • IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Ironwood Releases New IBS-C and CIC Data at the American College of Gastroenterology 2023 Annual Scientific Meeting

Retrieved on: 
Monday, October 23, 2023

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global GI-focused healthcare company, presented new data from four scientific abstracts during the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting and Postgraduate Course.

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a global GI-focused healthcare company, presented new data from four scientific abstracts during the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting and Postgraduate Course.
  • “The data presented at ACG peel back the many layers of these disorders’ impact.
  • While pain is usually associated with IBS-C, it also can be experienced by those with CIC and both patient groups can be affected by anal/rectal-related adverse consequences.
  • Non-D-IBS and CIC cases had higher costs versus controls on both a per-patient and a per-utilization basis.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Sunday, October 22, 2023

DUBLIN, Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

Key Points: 
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
  • If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Clinical Trial for SB15, a Proposed Biosimilar to Eyleaⁱ (Aflibercept), at EURETINA 2023

Retrieved on: 
Saturday, October 7, 2023

The aim of the post-hoc analysis was to find out biosimilarity between SB15 and reference aflibercept.

Key Points: 
  • The aim of the post-hoc analysis was to find out biosimilarity between SB15 and reference aflibercept.
  • This post-hoc analysis demonstrated that switching to SB15 from AFL maintained comparable clinical efficacy and safety in treating patients with neovascular age-related macular degeneration (nAMD), confirming biosimilarity between these agents before and after switching.
  • The primary endpoint was change from baseline in best corrected visual acuity (BCVA) at week 8; all endpoints were followed through week 56.
  • There were no additional safety signals identified and the immunogenicity profile was also similar after switching.

Scilex Holding Company Presented Oral and Poster Presentations on Elyxyb at the 2023 Annual Brain Week Conference Held in Las Vegas, NV

Retrieved on: 
Tuesday, September 12, 2023

PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual Brain Week Conference on the benefits of Elyxyb (celecoxib oral solution).

Key Points: 
  • PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual Brain Week Conference on the benefits of Elyxyb (celecoxib oral solution).
  • The conference was held from September 6-8, 2023 in Las Vegas, NV.
  • Taken together, these data suggest that to achieve pain freedom with Elyxyb, fewer patients need to be treated and may have less likelihood of being harmed, than with ubrogepant or rimegepant.
  • Elyxyb is a remarkable addition to armamentarium for treatment of acute migraine.” said Stewart Tepper, MD, The New England Institute for Neurology and Headache, Stamford, CT, USA.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on: 
Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points: 
  • — Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
  • This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
  • "Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
  • This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on: 
Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points: 
  • — Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
  • This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
  • "Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
  • This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Teva to Present Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023

Retrieved on: 
Wednesday, September 6, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.
  • Abstracts include data for AUSTEDO, once-daily AUSTEDO XR, UZEDY, TV-44749 and AJOVY.
  • Once-daily AUSTEDO XR, a new formulation of twice-daily AUSTEDO was approved by the U.S. Food and Drug administration (FDA) in February 2023 for adults with TD and chorea associated with Huntington’s disease (HD), and UZEDY, a long-acting formulation of risperidone for subcutaneous use, was approved by the FDA in April 2023 for adults with schizophrenia.1,2 TV-44749 is an investigational formulation of olanzapine currently being studied in adults with schizophrenia.3
    “Because of the immense impact that mental health and neurological conditions like schizophrenia, TD and HD pose for patients, we are constantly striving to advance research that can enhance available treatment options,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
  • “Following this year’s FDA approval of once-daily AUSTEDO XR and UZEDY and the excitement they have received from the medical community, we are thrilled to continue to share research showcasing their potential for patients living with these debilitating conditions.”
    In addition to these data presentations, Teva will also be hosting a symposium to discuss results of the DECIDE study, highlighting perspectives from U.S. psychiatric clinicians on selecting and initiating LAI antipsychotics as well as the real-world barriers that cause LAIs to remain underutilized in clinical practice.