Vycavert (10 mg hydrocodone bitartrate/325 mg acetaminophen) / Acura Pharma - LARVOL DELTA

"$ACUR Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03 https://t.co/4vFkuSq19M" (@otcdynamics)

"Not using much Cangrelor. If IV antiplt is needed, I go with bolus 2b3a or bolus + short infusion." - SVRaoMD

Biosimilar

Prophylactic Gabapentin Combined with Methadone Improves Overall Health in Patients Undergoing Chemoradiation for Head and Neck Cancer While Reducing Use of Opioids with High Abuse Potential: Early Results of a Prospective Randomized Trial (ASTRO 2018) - "...Materials/ Pts with Stage II-IV HNC who were treated with definitive CRT were randomized to one of two pain regimens: 1) High-dose GABA (900mg TID) with hydrocodone-acetaminophen followed by transdermal fentanyl as needed (HD-HAF) or 2) Low-dose GABA (300mg TID) with methadone (5-15mg BID) and oxycodone as needed (LD-MTD)... This study demonstrates that both pain regimens are safe and well tolerated. Methadone is associated with better overall health at the end of treatment for pts undergoing CRT. Our next study will utilize high dose GABA and methadone."

Clinical • Head and Neck Cancer • Oncology • Solid Tumor

Intravenous morphine titration vs. oral hydrocodone/acetaminophen for adults with lower extremity displaced fracture in an emergency department setting: A randomized controlled trial. (PubMed, Exp Ther Med) - "The incidence of short-term adverse events was similar between the 2 groups but sedation, whose incidence in the morphine group was markedly increased, may not be arbitrarily attributed to adverse events. It was concluded that, compared with oral hydrocodone/acetaminophen, intravenous morphine titration provided a rapid and sufficient pain relief and equivalent short-term adverse events for patients with lower extremity displaced fracture in an ED setting. "

Clinical • Journal • Biosimilar • CNS Disorders • Pain

Acura Pharmaceuticals' CEO discusses Q4 2013 results - Earnings call transcript (SeekingAlpha) - "Separately we have commenced the remaining clinical studies, studies 302, 303, and 304 for our Aversion Hydrocodone Acetaminophen product. These are the pharmacokinetics studies requested by the FDA to support safety and efficacy, we expect the results from these studies to be available in the third quarter of this year."

Anticipated PK/PD data • Pain

Heavy Metal Psychosis: Not the Music (APA 2017) - " In much of the available literature, the triad of alopecia, abdominal complaints and neuropathy is considered “pathognomonic” for thallium toxicity. This case is not only an account of a rare disease process but also a learning opportunity on many accounts."

Clinical • Biosimilar • CNS Disorders • Complement-mediated Rare Disorders • Epilepsy • Gene Therapies • Immunology • Pain • Rare Diseases • Venous Thromboembolism

A Case of a False-Positive Urine Pregnancy Test and Delayed Diagnosis of Obstructive Pyelonephritis. (PubMed, Am J Case Rep) - "She was treated with antibiotics, including cefazoline, and a left nephrostomy tube was sited to treat her hydronephrosis...Four days after her initial hospital admission, the patient was stable enough to go home on oral levofloxacin and pain medication. CONCLUSIONS This case of a false-positive urine pregnancy test in a 28-year-old woman with a history of tubal ligation highlights that this association may result in the delay in the diagnosis and treatment of acute pyelonephritis."

Clinical • Journal

Pharmacological strategies in multimodal analgesia for adults scheduled for ambulatory surgery. (PubMed, Curr Opin Anaesthesiol) - "These strategies must combine three key components when not contraindicated: regional/local analgesia, acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs). Adjuvants such as gabapentinoids, N-methyl-D-aspartate receptor modulators, glucocorticoids, α2-adrenergic receptor agonists, intravenous lidocaine might be added to the initial multimodal strategy, however, caution must be used regarding their side effects and risks of delaying recovery after ambulatory surgery. Weaker opioids (e.g. oxycodone, hydrocodone, tramadol) could be used rather than more powerful ones (e.g. morphine, hydromorphone, inhaled fentanyl, sufentanil). This, combined with education about postoperative weaning of opioids after surgery must be done in order to avoid long-term reliance of these drugs."

Clinical • Journal

Understanding multi-pill ingestion of prescription opioids: Prevalence, characteristics, and motivation. (PubMed, Pharmacoepidemiol Drug Saf) - "These results indicate that the ingestion of multiple opioid pills/tablets is extremely common among treatment-seeking opioid users. This, and other forms of non-medical oral use of prescription opioids, should be taken under consideration when developing prevention and intervention efforts targeting the opioid epidemic."

Journal

Opioids: A Review of Pharmacokinetics and Pharmacodynamics in Neonates, Infants, and Children. (PubMed, Eur J Drug Metab Pharmacokinet) - "Mild pain is usually managed quite well with oral acetaminophen or ibuprofen...This review provides pharmacokinetic and pharmacodynamic evidence on the currently available opioids: morphine, fentanyl (and derivatives), codeine, meperidine, oxycodone, hydrocodone, hydromorphone, methadone, buprenorphine, butorphanol, nalbuphine, pentazocin, ketobemidone, tramadol, piritramide, naloxone and naltrexone...Outside the premature and neonatal population, the use of opioids in infants, children, and adolescents quickly begins to resemble the established values found in adults. As such, the concerns (risks) of these medications become comparable to those seen in adults."

Clinical • Journal • PK/PD data • Review

A case of HGB S/O Arab’s disease in a hispanic male, case report and literature review (WSMRF 2020) - "He had stopped his daily hydroxyurea and folic acid approximately 3 months prior...We present the first documented and reported case of Hb S/OArab in a Hispanic male. The gene frequency of Hb S/OArab is unknown, though, per Zimmerman et.al., of the estimated 1500-2000 sickle cell infants born each year, it is possible that several of them are Hb S/OArab cases."

Clinical

Association of Opioid Prescribing With Opioid Consumption After Surgery in Michigan. (PubMed, JAMA Surg) - "The quantity of opioid prescribed is associated with higher patient-reported opioid consumption. Using patient-reported opioid consumption to develop better prescribing practices is an important step in combating the opioid epidemic."

Journal

Association Between Intravenous Acetaminophen and Opioid Use in Postoperative Management of Patients Following Congenital Heart Defect Repair (AHA 2019) - "Fentanyl, midazolam, lorazepam and hydrocodone/APAP use trended lower in the IV APAP group, but did not meet statistical significance. Time to extubation, sedation scores, liver enzymes, and serum total bilirubin levels were similar in both groups. Conclusion Patients with ASD, VSD, or TOF who received IV APAP after heart surgery required statistically significant less morphine in the first 48hrs after surgery than those patients who did not receive IV APAP."

Clinical

Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Utilization. (PubMed, J Am Coll Surg) - "Postoperative patients may consume less than half of the opioid pills they are prescribed. More research is needed to standardize opioid prescriptions for postoperative pain management while reducing opioid diversion."

Clinical • Journal

Pharmacokinetics and Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone, After Intranasal Administration in Recreational Drug Users. (PubMed, Pain Med) - "Drug Liking score, as assessed by maximal liking (Emax), was significantly lower for benzhydrocodone API vs HB API (P = 0.004), with 45% of subjects showing a ≥ 30% reduction in Drug Liking Emax. Reductions in hydrocodone exposure and associated decreases in Drug Liking relative to HB suggest that the prodrug benzhydrocodone may deter intranasal abuse."

Journal

Post-Discharge Opioid Consumption after Colectomy: Does Operative Approach Matter? (ASCRS 2019) - "Our study supports an overall reduction in opioid prescribing for both minimally invasive and open colectomy. Further work to identify patients who may not require opioids after surgery may contribute toward the greatest reduction in opioid prescribing."

Quantifying Opioid Use after Renal Transplantation (ATC 2019) - "These data indicate most patients require far fewer opioid pills to control post-operative pain than originally prescribed at discharge (77.5mg used vs. 175mg prescribed). We have implemented an early surgical follow up pathway after kidney transplant that allows us to reduce the quantity of hydrocodone/acetaminophen 5/325 mg prescribed at discharge from 35 tablets (175mg MME) to 20 tablets (100mg MME) while ensuring adequate post op pain control."

Shoulder Pain-- Range of Motion (ACSM 2019) - "History: 49-year-old female with rheumatoid arthritis on methotrexate and oral prednisone presents to the walk-in orthopedic injury clinic for acute severe sharp pain in left shoulder radiating into left elbow and hand... Shoulder Xray Final/working Diagnosis: Varicella zoster virus in C6 Dermatome Treatment and Outcomes: 1. Valacyclovir prescription: 1g tablet by mouth TID for 7 days 2. Pain control with Hydrocodone-acetaminophen 5-325mg per tablet QID PRN for pain 3."

Finding Truth from Two False-Positives (ENDO 2019) - "...His medications include alprazolam for anxiety, hydrocodone/acetaminophen for chronic back pain, valproic acid for mood-stablilizing, and escitalopram for depression...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"