Hydromorphone

Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, March 18, 2024
Research, Epilepsy, PO, Seizure, Partnership, Risk, Patient, Tramadol, Acquisition, American Epilepsy Society, GABAA, Enrollment, NRF1, SBMA, Schedule, Hydromorphone, Society, Therapy, DSM-IV codes, Safety, GAERS, Morphine, Pain, FDA, AES, Annual general meeting, Food, Pharmaceutical industry

MIAMI, March 18, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the year ended December 31, 2023.

Key Points: 
  • “We made considerable progress across our pipeline of differentiated neurologic therapies in 2023," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
  • Pending additional financing, we look forward to progressing BAER-101 and IV tramadol for patients facing great unmet need.
  • R&D Expenses: Research and development expenses for the full year 2023 were $6.1 million, compared to $2.7 million in 2022.
  • G&A Expenses: General and administrative expenses for the full year 2023 were $4.2 million, compared to $5.3 million in 2022.

CHLA Researchers Find That Length of Opioid Treatment for Hospitalized Infants Differs by Institution and Geography

Retrieved on: 
Tuesday, March 12, 2024
Other Health, Research, Pharmaceutical, Family, Consumer, Hospitals, Children, Science, Surgery, Baby, Maternity, Other Science, Health, JAMA Network Open, Ventricular septal defect, Risk, Infant, Prescription, MD, Methadone, MSHS, Hydromorphone, Morphine, Multimedia, Paper, Policy, Intubation, Fentanyl

View the full release here: https://www.businesswire.com/news/home/20240312681130/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240312681130/en/
    In a study published in JAMA Network Open, researchers at Children’s Hospital Los Angeles found the opioid treatment that critically ill, hospitalized infants received depended on their location.
  • The length of time the infants were prescribed opioids differed by geographic region across the U.S.— the Northeast, South, Midwest or West.
  • “Additionally, prolonged opioid exposure in high-risk hospitalized infants has been implicated in worsening neurodevelopmental outcomes,” Dr. Keane says.
  • During their hospital stay, 76% of infants were prescribed opioids such as fentanyl, morphine and hydromorphone, and about 8% received methadone.

Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol

Retrieved on: 
Thursday, January 4, 2024
Patient, Schedule, Partnership, Food, Tramadol, Pain, FDA, Therapy, Clinical trial, Element, Hypoventilation, CRL, DSM-IV codes, Safety, Hydromorphone, Morphine, Pharmaceutical industry

The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

Key Points: 
  • The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.
  • “We have worked collaboratively with the FDA over the last year to design a study that will address a theoretical safety risk.
  • The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period.
  • Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in two Phase 3 efficacy trials.

Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, November 13, 2023
CNS, Annual general meeting, Safety, American Epilepsy Society, Food, SBMA, D, Therapy, NRF1, Data, Patient, Research, DSM-IV codes, U.S. FDA, Neurology, FDA, Hydromorphone, Pain, Seizure, Tramadol, Generalized tonic–clonic seizure, Morphine, PO, AES, Pharmaceutical industry, Video game, Avenue, MIAMI

MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2023.

Key Points: 
  • “In the third quarter, Avenue continued to successfully execute across our pipeline of innovative CNS treatments," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
  • Topline data for the Phase 1b/2a clinical trial of AJ201 in SBMA are expected in the second quarter of 2024.
  • R&D Expenses: Research and development expenses for the third quarter of 2023 were $0.9 million, compared to $0.2 million for the third quarter of 2022.
  • G&A Expenses: General and administrative expenses for the third quarter of 2023 were $1.2 million, compared to $0.5 million for the third quarter of 2022.

Sorrento Therapeutics Announces Positive Phase 2a Clinical Trial Results for Resiniferatoxin (RTX) for the Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients

Retrieved on: 
Thursday, September 7, 2023
HTN, AE, Lidocaine, OAK, Oxycodone, Aes, Clinical trial, ECG, Capsaicin, Bankruptcy, Female, Pain, Hypertension, SPID, SAE, Patient, Standard of care, WOMAC, KOOS, SAN, OTC, Hydromorphone, BMI, FDA, Therapy, Triamcinolone acetonide, RTX, Safety, Pharmaceutical industry, Birth control

RTX 20mcg and 12.5mcg have been selected as the clinically optimal and minimally effective doses for further phase 2 pivotal or phase 3 trials.

Key Points: 
  • RTX 20mcg and 12.5mcg have been selected as the clinically optimal and minimally effective doses for further phase 2 pivotal or phase 3 trials.
  • SAN DIEGO, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ, "Sorrento") announced today positive Phase 2a top-line clinical trial results for the RTX program.
  • A higher proportion of patients responded to treatment with RTX 20mcg than any other treatment group, including Zilretta.
  • The clinical trial confirmed the potential of resiniferatoxin (RTX) in helping patients with moderate to severe osteoarthritis pain for at least 6 months, if not longer.

Avenue Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, August 10, 2023
Epilepsy, DSM-IV codes, Seizure, Spinal and bulbar muscular atrophy, IV, Symantec Endpoint Protection, PO, Anterior grey column, Schedule, SBMA, Pain, U.S. FDA, Morphine, Patient, Hydromorphone, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tramadol, Food, Safety, Generalized tonic–clonic seizure, D, Pharmaceutical industry, Avenue

MIAMI, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2023.

Key Points: 
  • Additionally, we reported promising preclinical results for BAER-101 that show robust anti-seizure activity in a translational animal model of absence epilepsy.
  • R&D Expenses: Research and development expenses for the second quarter of 2023 were $3.0 million, compared to $0.2 million for the second quarter of 2022.
  • G&A Expenses: General and administrative expenses for the second quarter of 2023 were $0.9 million, compared to $0.5 million for the second quarter of 2022.
  • Net Loss: Net loss attributable to common stockholders for the second quarter of 2023 was $4.0 million, or $0.52 per share, compared to a net loss of $0.6 million, or $0.41 per share, for the second quarter of 2022.

Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV Tramadol

Retrieved on: 
Tuesday, July 25, 2023
Epilepsy, DSM-IV codes, Partnership, IV, Element, Schedule, Pain, Morphine, Patient, Physician, Hypoventilation, Norepinephrine, Hydromorphone, Serotonin, FDA, Therapy, Tramadol, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Avenue

The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

Key Points: 
  • The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.
  • The study will randomize post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period.
  • Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in a Phase 3 efficacy trial.
  • We remain committed to Avenue’s mission of delivering impactful therapies to treat patients with neurologic diseases, while building shareholder value,” said Dr. MacLean.

NEW USE OF OPIOIDS INCREASES RISK OF DEATH ELEVENFOLD IN OLDER ADULTS WITH DEMENTIA

Retrieved on: 
Tuesday, July 18, 2023
Myenteric plexus, Copenhagen University Hospital, Face, Alzheimer's disease, D.O, Buprenorphine, Oxycodone, Research, Pharmacy, Falls, Ketobemidone, Pethidine, CDC, Pain, Dementia, Morphine, Guideline, Risk, Hypoventilation, Effectiveness, Hydromorphone, Confusion, Mortality, Ageing, Death, Fentanyl, Family, Conference, Disease, Residential care, Generic drug, Pharmaceutical industry

AMSTERDAM, July 18, 2023 /PRNewswire/ -- New opioid use in older adults with dementia is associated with a significantly increased risk of death, including an elevenfold increase in the first two weeks, according to research first reported today at the Alzheimer's Association International Conference® (AAIC®) 2023, in Amsterdam, Netherlands, and online.

Key Points: 
  • Older adults who start on opioids after a dementia diagnosis face heightened risk of death, especially in the first two weeks of opioid use.
  • They also followed a group of older adults with dementia who did not receive an opioid prescription and compared risk of death between the two groups.
  • The risk was greatest in the first 14 days, where mortality for all opioids was increased elevenfold.
  • This is not the first time that drugs have been found to be excessively risky for older people with dementia.

Capella Provides Exploration Update for the Løkken Copper Project, Norway

Retrieved on: 
Tuesday, December 13, 2022
Society, Metallurgy, VMS, Anomaly, Society of Economic Geologists, Australasian Institute of Mining and Metallurgy, Soil, University, 3D, VR Class Rro, News, NI, Lac Minerals Ltd v International Corona Resources Ltd, FRA, SEG, Mining, Oil, Capella, Hydromorphone

VANCOUVER, BC, Dec. 13, 2022 /PRNewswire/ - Capella Minerals Ltd (TSXV: CMIL) (OTCQB: CMILF) (FRA: N7D2) ("Capella" or the "Company") is pleased to provide the following update on exploration and drill targeting activities at the Company's 100%-owned Lkken copper-cobalt-zinc massive sulfide ("VMS") project in Trndelag province, central Norway.

Key Points: 
  • VANCOUVER, BC, Dec. 13, 2022 /PRNewswire/ - Capella Minerals Ltd (TSXV: CMIL) (OTCQB: CMILF) (FRA: N7D2) ("Capella" or the "Company") is pleased to provide the following update on exploration and drill targeting activities at the Company's 100%-owned Lkken copper-cobalt-zinc massive sulfide ("VMS") project in Trndelag province, central Norway.
  • Capella's recent exploration activities have been focused on advancing the five priority satellite targets that surround the former Lkken copper mining operations, with the main focus being the highly prospective Lkken-Hydal-mot corridor (Figure 1).
  • High-grade copper mineralization at the former Lkken mine is hosted by a sequence of Ordovician-age metabasalts (mixed pillow and massive basalts) within an overturned ophiolite sequence.
  • Mr. Roth has 30 years of experience in international minerals exploration and mining project evaluation.

Public Advisory - Recall of one lot of pms-Hydromorphone due to packaging error that could potentially lead to overdose

Retrieved on: 
Saturday, August 20, 2022
Tablet, Somnolence, Caregiver, Pain, Opioid use disorder, Hydromorphone, Dizziness, Death, Drug, Department, Government of Assam, Seizure, Health Canada, Inc., Patient, Pharmacy, Confusion, Naloxone, Coma, Wine, Medical device, Health insurance

The 2 mg hydromorphone tablets are round and orange with a "2" on one side of the tablet and "pms" on the other side.

Key Points: 
  • The 2 mg hydromorphone tablets are round and orange with a "2" on one side of the tablet and "pms" on the other side.
  • The 8 mg hydromorphone tablets are round and white with an "8" on one side of the tablet and "pms" on the other side.
  • The Department is monitoring the company's recall and will inform the public if any new health risks are identified.
  • The 8 mg hydromorphone tablets are round and white with an "8" on one side of the tablet and "pms" on the other side.