Last update 30 Jun 2024

Codeine Sulfate

Last update 30 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCodeine, a diminutive molecular compound, exerts its agonistic influence upon opioid receptors situated within the central nervous system. These receptor bindings have the consequential effect of engendering an array of variously potentiated pharmacological repercussions, most notably inclusive of analgesia and sedation. Invariably, this drug is ubiquitously leveraged in the management of moderate to severe pain, especially within clinical scenarios where less efficacious non-opioid analgesics do not suffice. Conceived and marketed by the Hikma Pharmaceuticals International Ltd., Codeine triumphantly garnered its inaugural regulatory endorsement in 2009. However, despite its overwhelming acceptance as an analgesic of preeminent standing, the expeditious recourse to Codeine is not without its associated drawbacks, notably the proclivity for consequential undesirable effects, inter alia, respiratory depression, constipation, and addiction. Ergo, its prescription is constrained to those cases where alternative pain relief modalities have failed to yield favorable outcomes.

Drug Type

Small molecule drug

Synonyms

Codeine sulfate (USP), Codeine sulfate trihydrate

Target

μ opioid receptor

Mechanism

μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System Diseases

Active Indication

Pain

Inactive Indication

Pain, Procedural

Originator Organization

West-Ward Pharmaceutical Corp.

Active Organization

Hikma Pharmaceuticals International Ltd.

Inactive Organization

Roxane Laboratories, Inc.

Drug Highest PhaseApproved

First Approval Date

US (16 Jul 2009),

Pain

Regulation-

Structure

Molecular FormulaC36H50N2O13S

InChIKeyBOLDZXRCJAJADM-AAXBYHQXSA-N

CAS Registry6854-40-6

Clinical Trials associated with Codeine Sulfate

NCT03478423 / TerminatedNot Applicable

A Blinded, Randomized Controlled Trial of Opioid Analgesics for the Management of Acute Fracture Pain in Adults Discharged From the Emergency Department

Background: Emergency department (ED) providers are frequently challenged with how best to treat acute pain, specifically when non-opioid analgesics are insufficient or contraindicated. Studies have documented older patients presenting to the ED with painful conditions are less likely to receive pain medications than younger patients, and this inadequate pain control has been associated with increased risk of delirium and longer hospital stays. Given the concerns for drug interactions, adverse side effects, over-sedation and addiction; emergency physicians often report uncertainty regarding the ideal choice of opioid analgesic in older adults. There are no guidelines informing best practice for the management of acute pain in this population.
Objective: The primary objective is to compare the efficacy of codeine, oxycodone and hydromorphone for acute fracture pain in patients discharged from the ED.
Methods: This will be a blinded, randomized controlled trial of adults (age ≥ 18) discharged home from the ED with acute pain secondary to an upper extremity, lower extremity, rib, pelvic or vertebral compression fracture. Patients will be randomized to receive a 3-day supply of codeine, oxycodone or hydromorphone. Patients will also be given acetaminophen. Patients will be contacted by phone or email 3 days following their ED visit. The primary outcome will be differences in pain scores at 3 days assessed using the validated Brief Pain Inventory (Short Form). Secondary outcomes will include side effects (ie: confusion, constipation), adverse events (i.e, falls, healthcare visits) and pain interference with daily activity. Patients, physicians and all research staff will be blinded to group allocation.
Importance: All analgesics (including opioids) prescribed to adults are associated with an increased risk of adverse events. This study seeks to inform ED providers of opioid efficacy, side effects and patient-important, functional outcomes in this growing patient population.

Start Date05 Feb 2018

Sponsor / Collaborator

Mount Sinai Hospital (Canada)

NCT03173456 / CompletedPhase 2IIT

Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department

This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).

Start Date28 Nov 2017

Sponsor / Collaborator

Albert Einstein College of Medicine, Inc.

EUCTR2017-002349-30-BE / Not yet recruitingPhase 4

Effect of codeine on pharyngeal and esophageal motility in healthy subjects: a double-blind, placebo-controlled, randomized, cross-over study

Start Date12 Sep 2017

Sponsor / Collaborator-

100 Clinical Results associated with Codeine Sulfate

100 Translational Medicine associated with Codeine Sulfate

100 Patents (Medical) associated with Codeine Sulfate

5,572

Literatures (Medical) associated with Codeine Sulfate

01 Mar 2024·Legal medicine (Tokyo, Japan)

Plastic bag suffocation and codeine overdose: An unusual case of complex suicide and review of the literature

Review

Author: Franceschetti, Lorenzo ; Tarozzi, Ilaria ; Rizzo, Amalia ; Bugelli, Valentina ; Chericoni, Silvio

The term "planned complex suicide" refers to cases where two or more suicide methods are applied simultaneously. Plastic bag suffocation is a suicidal method commonly combined with self-poisoning by inhalation of volatile compounds or pharmacological substances at poisoning dosage. A 67-year-old woman was found dead on the couch. The head was wrapped in a plastic bag knotted at the front of the neck. No signs of struggle were present on the scene. In the fireplace, there were two blisters of acetaminophen/codeine phosphate tablets. Postmortem examination showed congestion of the face and the neck and pulmonary edema with patchy emphysema. There was no evidence of physical duress. Toxic levels of codeine were detected in the blood. The death was related to a complex suicide involving codeine overdose and asphyxia by plastic bag suffocation. The hypoxic/cardioinhibitory effects of plastic bag suffocation combined to codeine-induced deep reduction of respiratory rate, making the suicide hypothesis the more likely scenario. In order to assess what elements contribute to postmortem diagnosis in complex suicides with plastic bag suffocation, a review of the forensic literature published between 2002 and 2022 was performed. This article emphasizes the complexity of diagnosing deaths involving plastic bag suffocation in suicides, particularly when combined with other methods like inert gas inhalation or drug intake. It underscores the importance of comprehensive toxicological analyses, careful scene examination, and histological studies, not forgetting a thorough comparative analysis of the existing literature, to accurately determine the cause and manner of death in such cases.

17 Feb 2024·Traffic injury prevention

A retrospective study of traffic offenses associated with driving under the influence of drugs in China

Article

Author: Li, Feng

OBJECTIVE:

This study aimed to investigate the prevalence and pattern of traffic offenses associated with driving under the influence of drugs (DUID) in 31 provinces of mainland China.

METHODS:

Traffic offenses were extracted from the nationally representative court file disclosure website. Drivers convicted of traffic offenses associated with DUID were included. The monthly percentage change (MPC) in rates was estimated by fitting negative binomial regression models to assess the time trends. Moran's I was used to determine the correlations of DUID-related rates among surrounding provinces.

RESULTS:

In total, 896 individuals convicted of DUID offenses were identified (April 2007 to March 2022). Of these, 769 individuals were involved in traffic crashes, and they killed 629 people. Regarding the types of drugs, 638 used amphetamine-type stimulants (ATS; methamphetamine, 3,4-methylenedioxymethamphetamine, amphetamine, and tenamfetamine), 104 used ketamine, 104 used opioids (heroin, morphine, methadone, codeine, and tramadol), 20 used caffeine, 4 used tetrahydrocannabinol, and 1 used gamma-hydroxybutyric acid. The offense trends among overall drug users (MPC, -1.1; p < .001) declined from 2014 to 2020. The trends also decreased for DUID-related traffic crashes (-1.5; p < .001) and deaths (-1.7; p < .001) during the same period. Except in three provinces, ATS-related offense rates were higher than opioid-related offense rates. Ketamine-related offense rates showed a significant positive correlation among the surrounding provinces (Moran's I, 0.22; p < .01), and South China had the highest ketamine-related offense rates.

CONCLUSIONS:

In the sample, the case fatality rate was 70.7%, which was a strong indicator of underreporting, and most minor DUID-related offenses could not be captured by Chinese court files. The frequency of drug screening tests for people should be increased. The traffic police in Qinghai, Tibet, and Xinjiang should always be equipped with fast screening test kits for drugs, which could increase the possibility of identifying DUID offenders.

01 Feb 2024·Drug metabolism and disposition: the biological fate of chemicals

Novel Independent Trans- and Cis-Genetic Variants Associated with CYP2D6 Expression and Activity in Human Livers

Article

Author: Smith, Dylan ; Shi, Jian ; Zhu, Hao-Jie ; He, Bing ; Wang, Xinwen

Cytochrome P450 2D6 (CYP2D6) is a critical hepatic drug-metabolizing enzyme in humans, responsible for metabolizing approximately 20%-25% of commonly used medications such as codeine, desipramine, fluvoxamine, paroxetine, and tamoxifen. The CYP2D6 gene is highly polymorphic, resulting in substantial interindividual variability in its catalytic function and the pharmacokinetics and therapeutic outcomes of its substrate drugs. Although many functional CYP2D6 variants have been discovered and validated, a significant portion of the variability in the expression and activity of CYP2D6 remains unexplained. In this study, we performed a genome-wide association study (GWAS) to identify novel variants associated with CYP2D6 protein expression in individual human livers, followed by a conditional analysis to control for the effect of functional CYP2D6 star alleles. We also examined their impact on hepatic CYP2D6 activity. Genotyping on a genome-wide scale was achieved using the Illumina Multi-Ethnic Genotyping Array (MEGA). A data-independent acquisition (DIA)-based proteomics method was used to quantify CYP2D6 protein concentrations. CYP2D6 activity was determined by measuring the dextromethorphan O-demethylation in individual human liver s9 fractions. The GWAS identified 44 single nuclear polymorphisms (SNPs) that are significantly associated with CYP2D6 protein expressions with a P value threshold of 5.0 × 10^-7 After the conditional analysis, five SNPs, including the cis-variants rs1807493 and rs1062753 and the trans-variants rs4073010, rs729559, and rs80274432, emerged as independent variants significantly correlated with hepatic CYP2D6 protein expressions. Notably, four of these SNPs, except for rs80274432, also exhibited a significant association with CYP2D6 activities in human livers, suggesting their potential as novel and independent cis- and trans-variants regulating CYP2D6. SIGNIFICANT STATEMENT: Using individual human livers, we identified four novel cis- and trans-pQTLs/aQTLs (protein quantitative trait loci/activity quantitative trait loci) of Cytochrome P450 2D6 (CYP2D6) that are independent from known functional CYP2D6 star alleles. This study connects the CYP2D6 gene expression and activity, enhancing our understanding of the genetic variants associated with CYP2D6 protein expression and activity, potentially advancing our insight into the interindividual variability in CYP2D6 substrate medication response.

News (Medical) associated with Codeine Sulfate

01 May 2024

·www.prnewswire.com

Opioid Withdrawal Syndrome Drug Market to Surge at a CAGR of 4.0% by 2034 | DelveInsight

According to DelveInsight's analysis, the current developmental pipeline for opioid withdrawal syndrome has multiple players; several companies have initiated clinical trials investigating new treatment options or studying how to use existing treatment options better. The dynamics of the opioid withdrawal syndrome market are also anticipated to change in the coming years, owing to the rise in healthcare spending globally. LAS VEGAS, May 1, 2024 /PRNewswire/ -- DelveInsight's Opioid Withdrawal Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, opioid withdrawal syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Opioid Withdrawal Syndrome Market Report According to DelveInsight's analysis, the market size for opioid withdrawal syndrome reached USD 1.3 billion in 2022 across the 7MM. Among the 7MM, the US captured the highest market in 2022, covering a total of 90% market, followed by the UK, which is anticipated to grow during the forecast period (2023–2034). In the US, the market mainly consisted of opioid agonist-antagonist, Alpha-2 adrenergic agonists and others, which generated nearly USD 1.1 million in 2022. According to DelveInsight estimations, nearly 9 million cases with long-term opioid usage were found in 2022 in the 7MM. Leading opioid withdrawal syndrome companies such as DemeRx IB, Inc., atai Life Sciences, MediciNova, BioXcel Therapeutics Inc., and others are developing novel opioid withdrawal syndrome drugs that can be available in the opioid withdrawal syndrome market in the coming years. The promising opioid withdrawal syndrome therapies in the pipeline include DMX-1002 (Ibogaine HCl), MN-166, BXCL501 , and others. Discover which therapies are expected to grab the major opioid withdrawal syndrome market share @ Opioid Withdrawal Syndrome Market Report Opioid Withdrawal Syndrome Overview Opioid withdrawal is a set of symptoms that occurs when opioids (such as µ-receptor agonists) are suddenly stopped, their use is reduced, or they are no longer taken for treatment. This can also happen when an opioid antagonist (like naltrexone or naloxone) or, in some cases, a partial opioid agonist (such as buprenorphine) is given to someone who has become physically dependent on opioids due to regular and persistent use. There isn't a specific test to diagnose opioid withdrawal, but it's important to conduct urine toxicology tests to rule out withdrawal from other drugs or combinations of drugs. Urine tests usually detect most opioids like morphine, heroin, codeine, oxycodone, and propoxyphene for about 12 to 36 hours after their use. However, methadone, buprenorphine, and LAAM (L-alpha-acetylmethadol) won't show up in standard urine tests for opioids and need specific testing. Additionally, urine tests for other substances like marijuana, cocaine, benzodiazepines, and amphetamines may often show positive results in opioid users. Other tests such as ECG, complete blood count (CBC), blood alcohol levels, and basic metabolic panel (BMP) should also be conducted. The severity of opioid withdrawal is commonly assessed using the Clinical Opioid Withdrawal Scale (COWS). Opioid Withdrawal Syndrome Epidemiology Segmentation As per DelveInsight's estimations, the total number of cases with opioid withdrawal syndrome in the United States were approximately 7 million in 2022 and are projected to decrease during the forecast period. The opioid withdrawal syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Number of Opioid Misuse Cases Number of Cases with Long-term Opioid Usage Total Opioid Withdrawal Symptoms Cases Opioid Withdrawal Syndrome Treatment Market The management of opioid use disorder and opioid withdrawal syndrome are intricately linked since they tackle various facets of the same fundamental problem: dependency on opioids and the difficulties it brings. Opioid use disorder treatment is centered on enduring control and recovery from opioid addiction, whereas opioid withdrawal syndrome treatment mainly deals with the immediate symptoms that emerge when people try to lessen or stop their opioid use. A successful approach to handling OWS is frequently a vital part of OUD treatment, especially during the detoxification stage when individuals might undergo severe withdrawal symptoms. Drugs employed to ease OWS can also contribute to treating OUD by aiding individuals in moving from reliance on opioids towards stability and eventual abstinence. These medications not only alleviate withdrawal signs but also diminish cravings, facilitating individuals' participation in behavioral therapies and other components of comprehensive OUD treatment. The management strategy for OWS varies depending on how severe the symptoms are for the person. When the withdrawal symptoms are mild, patients are advised to focus on staying hydrated by drinking at least 2–3 liters of water each day. Additionally, taking vitamin B and C supplements may be helpful in maintaining overall health. Generally, managing mild symptoms involves providing symptomatic treatment and supportive care, aiming to ease discomfort and ensure the patient's well-being during this period. In instances of greater severity, drugs such as methadone or codeine phosphate might be contemplated, especially for those needing detoxification from opioids with longer-lasting effects. These medications can ease withdrawal symptoms and diminish cravings, but cautious supervision and dosage adjustments are vital to ensure safety and efficacy. To know more about opioid withdrawal syndrome treatment guidelines, visit @ Opioid Withdrawal Syndrome Management Opioid Withdrawal Syndrome Pipeline Therapies and Key Companies DMX-1002 (Ibogaine HCl): DemeRx IB, Inc./atai Life Sciences MN-166: MediciNova BXCL501: BioXcel Therapeutics Inc. Learn more about the FDA-approved drugs for opioid withdrawal syndrome @ Drugs for Opioid Withdrawal Syndrome Treatment Opioid Withdrawal Syndrome Market Dynamics The dynamics of the opioid withdrawal syndrome market are expected to change in the coming years. Globally, the recognition of the opioid crisis and the necessity for effective treatments, including medications and behavioral therapies, has prompted pharmaceutical companies to invest in research and development, while government initiatives prioritize opioid withdrawal management, fostering opioid withdrawal syndrome market growth and opportunities for companies. The shift towards precision medicine also offers possibilities for developing targeted treatments, addressing the high prevalence of opioid addiction, and creating significant market demand for withdrawal syndrome treatments, potentially leading to substantial growth with the introduction of therapies featuring novel mechanisms, alongside the dominance of buprenorphine-based products in the current and emerging opioid withdrawal syndrome market. Furthermore, many potential therapies are being investigated for the treatment of opioid withdrawal syndrome, and it is safe to predict that the treatment space will significantly impact the opioid withdrawal syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the opioid withdrawal syndrome market in the 7MM. However several factors may impede the growth of the opioid withdrawal syndrome market. The stigma surrounding opioid addiction and withdrawal persists, potentially dissuading individuals from pursuing treatment or utilizing the resources available to them, despite advancements. The range of treatments for opioid withdrawal syndrome is still somewhat limited, necessitating more effective and accessible options. Stringent regulatory requirements and lengthy approval processes could delay the introduction of new OWS therapies to the market, hampering innovation, while economic downturns or changes in healthcare policies might impact funding for opioid addiction treatment programs and access to care, posing a threat to the OWS market and potentially compromising patient care and therapeutic effectiveness. Moreover, opioid withdrawal syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the opioid withdrawal syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the opioid withdrawal syndrome market growth. Scope of the Opioid Withdrawal Syndrome Market Report Therapeutic Assessment: Opioid Withdrawal Syndrome current marketed and emerging therapies Opioid Withdrawal Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Opioid Withdrawal Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Opioid Withdrawal Syndrome Market Access and Reimbursement Discover more about opioid withdrawal syndrome drugs in development @ Opioid Withdrawal Syndrome Clinical Trials Table of Contents Related Reports Opioid Withdrawal Syndrome Pipeline Opioid Withdrawal Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key opioid withdrawal syndrome companies, including Chiesi Farmaceutici S.p.A., BioXcel Therapeutics, Aphios Pharmaceutical, among others. Opioid Withdrawal Syndrome Epidemiology Opioid Withdrawal Syndrome Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted opioid withdrawal syndrome epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Opioid Use Disorder Market Opioid Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key opioid use disorder companies, including Braeburn Pharmaceuticals, BioXcel Therapeutics, MediciNova, AstraZeneca, Cerevel Therapeutics, LLC, Indivior Inc., Aptinyx, among others. Opioid Dependence Market Opioid Dependence Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key opioid dependence companies, including GW Pharmaceuticals, Opiant Pharmaceuticals, ATAI Life Sciences, C4X Discovery, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

21 Feb 2024

·www.pharmaceutical-technology.com

MHRA bans OTC sale of codeine after recreational abuse reports

Recent safety information has shown that codeine linctus is being misused recreationally for its opioid effects, instead of its intended use as a cough medicine. Credit: New Africa via Shutterstock. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that codeine linctus is to be reclassified as a prescription-only medicine due to the risk of abuse, dependency and overdose. This follows a consultation launched by the MHRA in July 2023 after Yellow Card reports indicated instances of the medicine being abused, rather than for its intended use as a cough suppressant. The consultation ran for four weeks, closing on 15 August 2023. Recent safety information indicates that codeine linctus is being misused recreationally for its opioid effects, instead of its intended use as a cough medicine. This poses a serious risk of addiction and potentially fatal overdose. Codeine linctus is an oral solution intended to treat adults with dry coughs. Opioid medications bind to specific receptors in the brain that reduce the perception of pain while also producing feelings of euphoria, relaxation, and sedation, making the drugs addictive, and potentially leading to dependence with prolonged use. Data from the Office for National Statistics revealed an increase in the annual number of deaths where codeine was involved from 88 deaths in 2011 to 200 deaths in 2021. See Also: MT-110 by Myosin Therapeutics for Substance (Drug) Abuse: Likelihood of Approval Xolair amplifies reach after FDA approval for treating food allergies In July 2023, the MHRA revealed a three-year corporate plan to create a quicker and more predictable legal landscape. The plan’s emphasis on the maintenance of public trust includes several initiatives, which include a pilot of public hearings on major safety issues throughout 2024 and 2025. In the announcement accompanying the reclassification, the MHRA’s chief safety officer Alison Cave said: “Patient safety is our top priority. Codeine linctus is an effective medicine for long-term dry cough, but as it is an opioid, its misuse and abuse can have major health consequences.” In the US, an ongoing opioid crisis demands alternatives to addictive pain medications. While some people are addicted to illicit opioids such as heroin, many are addicted to legal drugs such as codeine. Earlier this year, Vertex Pharmaceuticals announced plans to submit a new drug application for its non-opioid pain medication to the US Food and Drug Administration following positive results from a Phase III programme, marking a significant development in the field.

Phase 3Clinical Result

16 Jan 2024

·www.drugs.com

FDA Says Marijuana Should Be Reclassified as Less Risky Drug

TUESDAY, Jan. 16, 2024 -- Citing research that revealed marijuana has less potential for abuse than other drugs with the same restrictions, scientists from the U.S. Food and Drug Administration say it should be reclassified as a less dangerous drug. Right now, cannabis is classified as a Schedule I controlled substance, a high-risk category that includes heroin and LSD. The move to reconsider the dangers of marijuana first began in 2022, when President Joe Biden asked U.S. Health and Human Services Secretary Xavier Becerra and the attorney general to begin reviewing how marijuana is scheduled under federal law. As part of that process, HHS Assistant Secretary for Health Adm. Rachel Levine, M.D., wrote a letter to the Drug Enforcement Administration in August supporting the reclassification of marijuana to a Schedule III drug, a list that includes ketamine, testosterone, and Tylenol with codeine. The FDA documents, which were posted online Friday, state that the agency recommends rescheduling marijuana because it meets three criteria: a lower potential for abuse than other Schedule I and II substances; an accepted medical use; and a low or moderate risk for physical dependence in people who abuse it. The National Institute on Drug Abuse backed the recommendation, the documents state. Although marijuana is widely used for recreational purposes, it does not seem to trigger the serious outcomes that drugs such as heroin, oxycodone, and cocaine do, the researchers stressed. The data also provide "some credible level of scientific support for some of the therapeutic uses for which marijuana is being used in clinical practice in the United States," namely anorexia, pain, and nausea and vomiting from chemotherapy, the researchers added. Finally, the scientists noted that marijuana withdrawal has only been reported in heavy, chronic users. And "the marijuana withdrawal syndrome appears to be relatively mild compared to the withdrawal syndrome associated with alcohol, which can include more serious symptoms such as agitation, paranoia, seizures, and even death," they added. If the agency follows the recommendations of its researchers, rescheduling marijuana could allow for more research, give cannabis businesses the ability to bank more freely, and have such firms no longer subject to a 40-year-old tax code that does not allow credits and deductions from income generated by sales of Schedule I and II substances, CNN reported. CNN Article Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Codeine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D03580	Codeine Sulfate	R05DA04	DB00318

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pain	US	Hikma Pharmaceuticals International Ltd.	16 Jul 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pain, Procedural	Phase 3	US	Roxane Laboratories, Inc.	01 Apr 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03173456 (CTgov)	Phase 2	Musculoskeletal Pain \| Acute Pain	600	400 ibuprofen/APAP (400 Ibuprofen/APAP)	acqcmutseu(pqnsrxcmfu) = yrdpusfkag zrqflocfzi (qhvrfxduwa, tynnwyegcx - mnpyamyyyb) View more	-	01 Feb 2022
				800 ibuprofen/APAP (800 Ibuprofen/APAP)	acqcmutseu(pqnsrxcmfu) = tztgzvdbov zrqflocfzi (qhvrfxduwa, fjuegddmrg - csfemzydqf) View more
NCT02625753 (Pubmed)	Phase 3	Add-on	40	Codeine plus acetaminophen	bogrqhlafd(wokykvbfmc) = No difference was observed in food intake xazikhugov (hzptbbcjtg ) View more	Positive	01 Jan 2021
				Placebo
NCT02295280 (CTgov)	Not Applicable	Headache	70	Metoclopramide+Diphenhydramine (Metoclopramide IV & Diphenhydramine IV)	hqwitytcmg(agokduuvlb) = dpubuxxyfi gkdbvczjvn (baivkuoqtw, pxrgtytqlc - fagyyqjpxd)	-	02 Apr 2018
				Codeine (Codeine)	hqwitytcmg(agokduuvlb) = owyybtjyyu gkdbvczjvn (baivkuoqtw, uaisubftky - xcvsravesa) View more
NCT01267136 (CTgov)	Phase 4	Pain \| Tonsillitis	84	Acetaminophen+Codeine (Capital® With Codeine Suspension)	rhhxypgjao(weamefuosz) = eeqkoifuoo vcjityadjx (pbzvweyfqg, potiqzqnji - jqngcesxml) View more	-	17 Apr 2014
				Tramadol suspension (Tramadol Suspension)	rhhxypgjao(weamefuosz) = eemfismlfj vcjityadjx (pbzvweyfqg, mtlswuhxol - mlmmalvtgt) View more
NCT01055704 (CTgov)	Phase 4	Gastrointestinal motility disorder	48	Placebo + placebo	foflfevmcm(hwtosmrhie) = pmicjzwcfe vmlxujucqi (ocztoxbugz, upswpaeajl - ojaaynpvkv) View more	-	08 Aug 2011
ASCO2006	Not Applicable	Neoplasms	150	Codeine	airnequamx(wkzvyyatfl) = lrfcbwsllq rbwdhdfqdh (fdwjlkpfqx ) View more	Positive	20 Jun 2006

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