Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain.

This study aimed to assess the tolerability of the extended use (≤35 days) of MNK-155, a biphasic (immediate-release/extended-release) hydrocodone bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain. METHODS: This Phase III, multicenter, open-label study enrolled patients with moderate to severe OA (knee or hip) pain despite the use of nonopioid or opioid analgesic agents, or with moderate to severe CLBP present for several hours per day for ≥3 months. Patients received a 3-tablet initial dose of IR/ER HB/APAP (total dose, 22.5/975 mg) on day 1, followed by 2 tablets of IR/ER HB/APAP (total dose, 15/650 mg) q12h for up to 35 days. Tolerability, the primary end point, was assessed using time to treatment discontinuation, the prevalence of treatment-emergent adverse events (TEAEs), vital sign measurements, pulse oximetry, clinical laboratory tests, and compliance. Secondary outcomes included the modified Brief Pain Inventory-Short Form, the Western Ontario and ...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Tags: Clin Ther Source Type: research

Related Links:

ConclusionsThis is the first demonstration that the value of pain follows a curvilinear function and is relative to the mean and standard deviation of competing monetary rewards. These new observations significantly contribute to our understanding of how pain is assigned value when making decisions between avoiding pain and obtaining rewards.
Source: European Journal of Pain - Category: Anesthesiology Authors: Tags: ORIGINAL ARTICLE Source Type: research
Today's materials from the Intraclear Biologics team may be of interest to those following the development of senolytic therapies. Since the Mayo Clinic has yet to publish results from their clinical trials of fisetin as a senolytic therapy, and may not do so for a few years yet, it is good to see even preliminary data from other sources. Senolytic therapies selectively destroy senescent cells, though only one approach (the combination of dasatinib and quercetin) has been definitely shown to destroy significant numbers of senescent cells in humans. Data has yet to be published on whether fisetin performs as well in humans ...
Source: Fight Aging! - Category: Research Authors: Tags: Self-Experimentation Source Type: blogs
Countries around the world are making preparations against omicron, a new variant of the novel coronavirus that causes COVID-19. Although it hasn ’t yet been detected in the United States (as of Nov. 29, 2021), health officials are once again cautioning the public about getting vaccinated, frequent testing and potentially stepping up tried-and-true measures to prevent transmission such as mask-wearing and hand-washing.We spoke with  Shangxin Yang, a pathologist at UCLA Health, about the new variant and what everyone needs to know.How is the omicron variant different from the delta variant and others?It has ...
Source: UCLA Newsroom: Health Sciences - Category: Universities & Medical Training Source Type: news
Source: Risk Management and Healthcare Policy - Category: Health Management Tags: Risk Management and Healthcare Policy Source Type: research
Contrast-enhanced ultrasound (CEUS) lymphosonography is useful in identifyin...Read more on AuntMinnie.comRelated Reading: AI could help with breast ultrasound workloads How ultrasound can help speed up winemaking DBT can help evaluate cases of focal breast pain POCUS making waves, but questions remain Ultrasound finds swollen glands on patients after COVID-19 vaccine
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news
Conclusion One of the ways to ensure you lead a happy and quality life is to take good care of your mental health continually. Practicing the habits discussed above will take you a step forward in staying mentally healthy. Do you have any bad mental health habits you struggle with? Can you commit to kicking them to the curb and practicing the above helpful mental health habits? We would appreciate your feedback in the comment section.   Sherry Kimball likes to write articles with advice that help people to improve their lives.  Sherry enjoys researching, discussing, and writing on the topics of ...
Source: PickTheBrain | Motivation and Self Improvement - Category: Consumer Health News Authors: Tags: featured happiness psychology habits mental health Source Type: blogs
In patients with knee osteoarthritis, telehealth-delivered exercise and diet programs are superior to electronic health information for reducing pain and improving function, a randomized trial shows.Reuters Health Information
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Orthopaedics News Source Type: news
In this study, we classified children into 9 subgroups based on their medical diagnosis or, for children without a specific diagnosis, their identified areas of developmental delay. We then analyzed data from the developmental assessment administered to each child on program entry and exit. Multivariate analyses of children's pre- and postscores in 5 domains (cognitive, motor, adaptive, communication, and personal–social) confirmed the distinctiveness of each subgroup's developmental profile on entry into EI as well as significant differences across subgroups in children's pattern of developmental change while in ser...
Source: Infants and Young Children - Category: Child Development Tags: Original Articles Source Type: research
"Even though I passed the Navy's physical requirements with excellent scores to become a Navy Nurse, I was still automatically disqualified because my amputation existed before service." Cvancara states.
Source: Forbes.com Healthcare News - Category: Pharmaceuticals Authors: Tags: Diversity, Equity & Inclusion /diversity-equity-inclusion Leadership /leadership Innovation /innovation Healthcare /healthcare Source Type: news
This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding” — Dr. Alex Belser, Cybin’s Chief Clinical Officer #7. Beacon Biosignals raises $27M to scale EEG, AI-based neurobiomarker discovery platform “analyzing EEGs is labor intensive and interpretation of these tests can vary from one clinician to another..…Beacon Biosignals has assembled what it claims is one of the world’s largest clinical EEG databases. By applying its proprietary machine-learning algorithms to the database, t...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Education & Lifelong Learning aducanumab Aduhelm Alzheimer's drug Beacon Biosignals Click Therapeutics Cognitive Behavioral Therapy Monitoring cognitive-bias cognitive-testing curiosity Cybin depression digit Source Type: blogs
More News: Acetaminophen | Arthritis | Back Pain | Chronic Pain | Common Cold | Constipation | Disability | Drugs & Pharmacology | Headache | Hydrocodone | Laboratory Medicine | Liver | Lortab | Low Back Pain | Migraine | Osteoarthritis | Pain | Pain Management | Rheumatology | Study | Universities | Urology & Nephrology | Vicodin | Women