Delving into the Latest Updates on Methocarbamol with Synapse

Overview

Basic Info

SummaryMethocarbamol, sold under the brand name Robaxin among others, is a medication used for short-term musculoskeletal pain. It may be used together with rest, physical therapy, and pain medication. It is less preferred in low back pain. It has limited use for rheumatoid arthritis and cerebral palsy. Effects generally begin within half an hour. It is taken by mouth or injection into a vein. Common side effect include headaches, sleepiness, and dizziness. Serious side effects may include anaphylaxis, liver problems, confusion, and seizures. Use is not recommended in pregnancy and breastfeeding. Because of risk of injury, skeletal muscle relaxants should generally be avoided in geriatric patients. Methocarbamol is a centrally acting muscle relaxant. How it works is unclear, but it does not appear to affect muscles directly.

Drug Type

Small molecule drug

Synonyms

(RS)-2-hydroxy-3-(2-methoxyphenoxy)propyl carbamate, Methocarbamol (JAN/USP/INN), Methocarbamol for Suspension

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Target

CA1

Mechanism

CA1 inhibitors(Carbonic anhydrase I inhibitors)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Musculoskeletal Pain

Inactive Indication-

Originator Organization

Endo International Plc

Active Organization

Hikma Pharmaceuticals USA, Inc.

Auxilium Pharmaceuticals LLC

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (16 Jul 1957),

Musculoskeletal Pain

Regulation-

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Structure

Molecular FormulaC11H15NO5

InChIKeyGNXFOGHNGIVQEH-UHFFFAOYSA-N

CAS Registry532-03-6

This is a Phase 3, randomized, double blind, multicenter study to evaluate the analgesic efficacy and safety of a single intra-articular dose of F14 (625 mg sustained release celecoxib) administered concurrent with multimodal analgesia in patients undergoing total knee replacement surgery, compared to multimodal analgesia alone.

Start Date17 Nov 2022

Sponsor / Collaborator

Arthritis Innovation Corp.

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NCT05388929 / RecruitingPhase 4IIT

Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study

The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair.
Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment.
Participants will be randomized into one of the study groups listed below.
Primary ventral hernia repair or inguinal hernia repair:
Group 1: standard opioid after surgery Group 2: methocarbamol after surgery
Open or robotic ventral hernia repair outpatient:
Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery
Open or robotic ventral hernia repair inpatient:
Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge
A total of 200 participants will be included in the study.
Participation will last for about 30 days after surgery.

Start Date23 Jun 2022

Sponsor / Collaborator

Prisma Health

NCT05076110 / RecruitingPhase 4

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.

Start Date07 Apr 2022

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Methocarbamol

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100 Translational Medicine associated with Methocarbamol

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100 Patents (Medical) associated with Methocarbamol

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271

Literatures (Medical) associated with Methocarbamol

01 Dec 2023·Therapeutic drug monitoring

Diverse Drug Classes Partition into Human Sweat: Implications for Both Sweat Fundamentals and for Therapeutic Drug Monitoring

Article

Author: Fay, Dan ; Buggele, William A ; Uchtman, Kara Fay ; Ruwe, Theresa ; Begtrup, Gavi ; Zebertavage, Aidan S ; Tracy, Timothy S ; Runnoe, David ; Daumeyer, Henry ; Yuan, Yuchan ; White, Evyn ; Heikenfeld, Jason

Abstract::

Therapeutic drug monitoring to optimize drug therapy typically relies on the inconvenience of repeated plasma sampling. Sweat is a potential alternative biofluid convenient for sampling. However, limited information exists regarding the range of drugs excreted in sweat and their correlation with plasma concentrations. This study evaluated drugs in sweat and plasma of an ambulatory clinical cohort. Pilocarpine-induced sweat was collected from ambulatory participants at a single instance using an absorbent nylon mesh, followed by concurrent blood sampling for ratio and correlation analyses. In a model drug study, the pharmacokinetics of acetaminophen in sweat and plasma were compared. Of the 14 drugs and 2 metabolites monitored in the clinical study, all compounds were present in sweat and plasma; however, the sweat-to-plasma ratio varied substantially across the drugs. Opioids and methocarbamol demonstrated the highest concentrations in sweat, sometimes exceeding plasma concentrations. Selected antidepressants and muscle relaxants were also detected in sweat at a 2–10-fold dilution to the plasma. Others, such as gabapentin and pregabalin, were highly diluted (>30-fold) in sweat compared with plasma. Together, these data suggest that molecular attributes, specifically hydrophobicity (logP) and charge state at physiologic pH (7.4), enable reasonable prediction of sweat-to-plasma drug correlation. These findings demonstrated that sweat could be used as an alternative biofluid for therapeutic drug monitoring. The findings also suggest that although it has been broadly accepted that small hydrophobic molecules most likely have a strong plasma correlation, there is a small window of hydrophobicity and charge state that permits sweat partitioning.

01 Dec 2023·Journal of pharmacy practice

Impact of an Enhanced Recovery after Surgery Protocol on Postoperative Outcomes in Cardiac Surgery

Article

Author: Wills, Brittany ; Bills, Stephanie ; Elbeery, Joseph ; Boyd, Samara

Background: Enhanced recovery after surgery (ERAS) protocols are perioperative care pathways designed to achieve early recovery after procedures. ERAS protocols have shown shortened recovery time, and lower opioid utilization and postoperative complication rates. Evidence to support the use of ERAS protocols is robust, however, minimal data exists in cardiac surgery patients. Methods: This observational cohort compared adults receiving post-operative care after coronary artery bypass or valve procedures who received an ERAS protocol containing acetaminophen, gabapentin, and methocarbamol to historical controls. The primary outcome of this study was postoperative opioid use during the first 72-hours following cardiac surgery. Secondary outcomes included length of stay, average pain scores 72-hours postoperatively, and incidence of opioid-related complications. Results: Total cumulative 72-hour post-operative opioid consumption showed a trend toward reduction in opioid use in patients who received the ERAS protocol vs the historic control group [75.8 mg vs 105.4 mg oral morphine equivalents (P = .09)]. Median postoperative lengths of stay and pain scores were similar between groups. Opioid related complications including constipation and respiratory depression occurred more frequently in the control group compared to the ERAS group [47.7% vs 60.5% ( P < .05) and 57.1% vs 62.7% ( P < .05) respectively]. Conclusions: Use of an ERAS protocol shows a promising trend toward less postoperative opioid use in cardiac surgery patients. Lower rates of opioid-related adverse events, including constipation and respiratory depression, were observed in the ERAS protocol group. This study indicates that ERAS protocols have a potential role for cardiac surgery patients postoperatively.

01 Dec 2023·American journal of surgery

Impact of methocarbamol on opioid use after ventral incisional hernia repair

Article

Author: Hammond, Brooke ; Crosier, Caitlin ; Carbonell, Alfredo M ; Blackhurst, Dawn ; Warren, Jeremy A ; Carbonell, Cecilia ; Desai, Shivani ; Love, Michael W ; Cobb, William S ; Hoffman, Katherine

BACKGROUND:

Alternatives to opioid analgesia are needed to reduce the risk of abuse, misuse, and diversion. Musculoskeletal pain is a significant contributor to postoperative pain after ventral hernia repair (VHR). We report the impact of methocarbamol on opioid prescribing after VHR.

METHODS:

Review of all robotic and open VHR, Jan 2020-July 2022. Data was collected in the Abdominal Core Health Quality Collaborative (ACHQC) with additional chart review to assess for opioid refills. A 2:1 propensity score match was performed comparing opioid prescribing in patients prescribed vs not prescribed methocarbamol.

RESULTS:

101 patients received methocarbamol compared with 202 without. Similar number of patients received an opioid prescription (87.1 vs 86.6%; p = 0.904). Study patients received significantly lower MME prescription at discharge (60 v 75; p = 0.021) with no difference in refills (12.5 vs 16.6%; p = 0.386).

CONCLUSION:

Addition of methocarbamol to a multimodal analgesic regimen after VHR facilitates reduction in prescribed opioid with no increase in refills.

6

News (Medical) associated with Methocarbamol

14 May 2024

·www.fiercepharma.com

Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year

Aurobindo's Eugia unit continues to be scrutinized by the FDA, racking up a fifth Form 483 since December. Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth Form 483 since December. The company’s latest slap from the U.S. regulator stems from an April 25 to May 3 inspection of its Bhiwadi sterile drug manufacturing unit in Rajasthan, India, which resulted in seven observations. The majority of the observations were related to workers not following procedures that are intended to prevent microbial contamination or the site lacking manufacturing processes to prevent contamination. In the first observation cited by the FDA, inspectors observed on several occasions operators performing a “manual intervention” by reaching over an aseptic line with their arms and upper torsos, blocking air flow. Such actions, the agency said, were observed in a July 2022 inspection that was determined to be the “root cause of a contaminated vial and subsequent media failure.” The facility was also cited for failing to have procedures in place that are designed to prevent contamination of drug products and for not thoroughly reviewing unexplained manufacturing discrepancies and batch failures. The facility produces sterile drug products that are sent to the U.S. and European markets. Prior to this FDA rebuke, Eugia sites in India received FDA Form 483 citations in April and twice in February, FDA records show. In December, the agency handed down a citation for a plant in New Jersey that Aurobindo has since agreed to sell. Separately, in early April, Eugia issued a voluntary recall of one lot of the muscle relaxant methocarbamol injection after a customer complained of finding white particles inside a vial.

02 Apr 2024

·www.fiercepharma.com

Aurobindo's Eugia recalls one lot of muscle relaxant because of possible contamination

Aurobindo subsidiary Eugia is voluntarily recalling one lot of methocarbamol injection following the possible discovery of white particles inside a vial. Eugia, a unit of India’s Aurobindo, issued a voluntary recall of one lot of methocarbamol injection after a customer complained about finding white particles inside a vial. The recall affects lot number 3MC23011 with an expiration date of November 2025, comprising 1,000 milligram/10-milliliter single-dose vials. The lot was distributed nationwide in January of this year, the company said in a letter posted to the FDA website and dated March 22. The company said it hasn’t received any reports of patient problems related to the recall. Methacrarbamol is typically used to treat discomfort related to musculoskeletal conditions. Eugia has recently come under FDA scrutiny following inspections at its facilities. In early March, the company was issued a Form 483 that outlined seven manufacturing problems at its injectables facility in Telangana, India. That rebuke fell shortly after the U.S. regulatory agency slammed Eugia with a Form 483 aimed at its former New Jersey facility where inspectors in December noted “construction activities” in a warehouse near the firm’s microbiology lab, which could have posed a contamination risk. In February, drug compounder Empower Pharmacy announced that it planned to buy the 170,000-square-foot Eugia facility for an undisclosed price and retain its workforce.

01 Nov 2022

·endpts.com

FDA warns Amazon again for selling unapproved drugs online

Slowly but surely the FDA is cracking down on the vast, illegal online sale of drugs made possible by behemoths like Amazon. In a warning letter dated Oct. 28, the FDA told Amazon CEO Andy Jassy that the company sold and distributed drugs with undeclared active ingredients that were marketed as dietary supplements. The FDA said it confirmed via lab analyses that the “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” purchased on Amazon.com contained the API of the NSAID pain drug diclofenac, which is not listed on the product labels. The letter follows a notice from last January in which the FDA warned the public not to purchase these products, which are promoted and sold for joint pain and arthritis. The FDA wrote at the time: The FDA ran additional lab analyses revealing in April that certain Artri and Ortiga products also contained dexamethasone, a corticosteroid, and the muscle relaxant methocarbamol, which can cause sedation, dizziness and low blood pressure. And in an update on its January warning, the agency said it has received adverse event reports linked to these Artri King products, including of liver toxicity and death, since the agency issued its first warning. This is the second time this year that the FDA has sent a warning letter to Jassy, with the first coming in August for selling mole removal products over-the-counter even though they were unapproved products. In both cases, the FDA purchased the drugs from Amazon.

100 Deals associated with Methocarbamol

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External Link

KEGG	Wiki	ATC	Drug Bank
D00402	Methocarbamol	M03BA03	DB00423

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Musculoskeletal Pain	US	Auxilium Pharmaceuticals LLC	16 Jul 1957

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISC2023	Not Applicable	Stroke	-	Methocarbamol	rokwgjjskl(mccocrvwwi): RR = 1.32 (95% CI, 1.19 - 1.44) View more	-	01 Feb 2023
				Cyclobenzaprine
NCT02432456 (CTgov)	Phase 4	Rib Fractures \| Acute Pain	153	Opioid+Acetaminophen+Pantoprazole+Methocarbamol+Ibuprofen (Placebo Infusion)	jcihaihkqp(hmspkypoep) = msodfbjtnv vsnnbrmuvm (vstfviugyh, vdrfclxgyn - ncnikdmoui) View more	-	05 Feb 2020
				Opioid+Acetaminophen+Pantoprazole+Methocarbamol+Ibuprofen+Ketamine (Ketamine Infusion)	jcihaihkqp(hmspkypoep) = klwqbpcnhn vsnnbrmuvm (vstfviugyh, pqvyxmjqsf - uxxtysbluk) View more
NCT02831569 (CTgov)	Phase 3	Low Back Pain \| Trigeminal Neuralgia \| syndrome; salt-losing, adrenogenital syndrome ... View more	80	Loxoprofen Sodium+Methocarbamol	rixgflmxvs(hlvpypswdg) = xawwxlisjg mjksejysdu (qxrmevbaqs, mbdlzkukbo - gqxgaxsmlu) View more	-	20 Jul 2018
NCT02665286 (CTgov)	Phase 4	Acute low back pain	240	Placebo+Naproxen (Placebo)	mgphjpnroo(lfbcabband) = bgmcohfvph mxixvoqlna (zwuebspfjm, cuxzzijvvg - srmyfvejeb) View more	-	26 Jun 2018
				Naproxen+Orphenadrine (Orphenadrine)	mgphjpnroo(lfbcabband) = twoxbexvmd mxixvoqlna (zwuebspfjm, couzhmhfta - zdhjgvuczu) View more
NCT02665286 (Pubmed \| Ann Emerg Med)	Phase 4	Acute low back pain	240	Naproxen+Placebo	uskpzdqhei(ladpwlliqa) = vopzkgxrev gbxcbidnie (elwssyeqty, 8.9 - 12.9)	Negative	01 Mar 2018
				Naproxen+Orphenadrine	uskpzdqhei(ladpwlliqa) = qaoxnvyfbd gbxcbidnie (elwssyeqty, 7.4 - 11.5)