Opioid Dependence - Pipeline Insight, 2024

This “Opioid Dependence- Pipeline Insight, 2024” report provides comprehensive insights about 35+ companies and 40+ pipeline drugs in Opioid Dependence pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Opioid Dependence: Understanding

Opioid Dependence: Overview

Opioid dependence is a disorder of regulation of opioid use arising from repeated or continuous use of opioids. The characteristic feature of dependence is a strong internal drive to use opioids, which manifests itself by an impaired ability to control use, increasing priority given to use over other activities, and persistence in use despite harm or negative consequences.

Opioids can lead to physical dependence within a short time, as little as 4-8 weeks. In other words, the body will become used to opioids so that it has difficulty functioning without them. With chronic use, abruptly stopping opioid use leads to withdrawal symptoms, including generalized pain, chills, cramps, diarrhoea, dilated pupils, restlessness, anxiety, nausea, vomiting, insomnia, and very intense cravings. However, people do not die from opioid withdrawal. Because these symptoms are severe, it creates significant motivation to continue using opioids to prevent withdrawal.

Dependence is associated with withdrawal syndrome, which occurs upon cessation of repeated exposure to a drug stimulus. Providers must advise patients not to stop taking chronic opioids without first tapering their medication dosage. Dependence is also a subset of a substance use disorder, manifesting as physical or psychological dependence or both. Opioid withdrawal onset varies with the type of opioid used but correlates with dependence.

Chronic opioid use causes alterations in receptor sensitivity, leading to medication tolerance and changes in pain perception. Opioid-induced hyperalgesia (OIH) causes pain perception out of proportion to the stimulus (hyperalgesia) in those who use or misuse opioids long-term.

Opioids binds to the receptors within the CNS as well as throughout the peripheral tissues. These receptors are normally stimulated by endogenous peptides (endorphins, enkephalins, and dynorphins) produced in response to noxious stimulation. Action on these same receptors induces intense euphoria. This causes many individuals to continue using with the intention of recreating that first high. Most people who misuse opioids do so for pain relief or to prevent withdrawal symptoms.

The development of effective treatments for opioid dependence is of great importance given the devastating consequences of the disease. Counseling and behavioral therapies may be an important part of treatment alongside medications; however, they are effective by themselves. Medications are also used to relieve cravings, relieve withdrawal symptoms, and block the euphoric effects of opioids. These medications do not “cure” the disorder but rather improve safety and prevent withdrawal symptoms, which can lead to relapse or continued drug use.

Opioid Dependence- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Opioid Dependence pipeline landscape is provided which includes the disease overview and Opioid Dependence treatment guidelines. The assessment part of the report embraces, in depth Opioid Dependence commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Opioid Dependence collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Opioid Dependence R&D. The therapies under development are focused on novel approaches to treat/improve Opioid Dependence.

Opioid Dependence Emerging Drugs Chapters

This segment of the Opioid Dependence report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Opioid Dependence Emerging Drugs

OX 124: OrexoOX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl. To meet the target profile for more potent rescue medications, Orexo has developed a novel and unique intranasal formulation technology that allows for rapid and efficient delivery of active ingredients through the intranasal route. Naloxone (OX-124) is under development for the treatment of drug overdose such as opioid overdose. The drug candidate acts by targeting opioid kappa, opioid delta, and opioid Mu receptors. It is administered as a nasal spray. It is developed based on amorphOX technology platform. Currently, the drug in the Preregistration Phase for the treatment of opioid dependence.

APH-1501: AphiosAPH-1501, is an investigational drug being developed by Aphios.APH-1501 belongs to the class of Cannabinoids. It acts as a Cannabinoid receptor modulator. APH-1501, Cannabidiol (CBD), a unique, bioactive component of marijuana, in reducing early attrition and improving outcome in opioid-dependent individual in adults diagnosed with an opioid addiction, ages 21-55 years of age. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of Opioid Dependence.

DMX-1002: DemeRx IB, Inc.DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence. DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002 is a GMP drug product manufactured for human use. Currently the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of Opiate Withdrawal Syndrome.

Noribogaine: DemeRx IB, Inc.NorIbogaine is an indole alkaloid with an atypical opioid pharmacology that may offer unique opportunities to improve the treatment of opioid addiction and to limit tolerance to opioid pain medications. It is also planned to develop NorIbogaine as a subchronic adjunct therapy to support patients after Ibogaine detoxification who are in early recovery. Noribogaine has pharmacologic properties that distinguish it from methadone, buprenorphine and the major opioid analgesics in clinical use. In animal models of addiction, noribogaine blocks opioid, cocaine, nicotine and alcohol self-administration suggesting that low dose Noribogaine may prove effective as an abstinence-based therapy for opioid and possibly other drug addictions. DemeRx has advanced NorIbogaine in first in human clinical trials. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of Opiate Withdrawal Syndrome.

Opioid Dependence: Therapeutic Assessment

This segment of the report provides insights about the different Opioid Dependence drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Opioid Dependence

• There are approx. 35+ key companies which are developing the therapies for Opioid Dependence. The companies which have their Opioid Dependence drug candidates in the most advanced stage, i.e. Preregistration Phase include, Orexo.

Phases

This report covers around 40+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Opioid Dependence pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Opioid Dependence: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Opioid Dependence therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Opioid Dependence drugs.

Opioid Dependence Report Insights

• Opioid Dependence Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Opioid Dependence Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Opioid Dependence drugs?
• How many Opioid Dependence drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Opioid Dependence?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Opioid Dependence therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Opioid Dependence and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Opiant Pharmaceuticals
• Orexo
• Aphios Pharma
• DemeRx IB, Inc.
• Alar Pharmaceuticals
• BioXcel Therapeutics
• Lyndra Therapeutics
• Trevena
• Aptinyx
• Indivior
• Cerevel Therapeutics
• BioCorRx
• Delpor
• AstraZeneca
• Gilgamesh Pharmaceuticals

Key Products

• OPNT-003
• OX 124
• APH 1501
• DMX-1002
• ALA-1000
• BXCL501
• LYN 014
• TRV-734
• NYX-783
• INDV-2000
• CVL-354
• BICX104
• DLP-160
• AZD-4041
• GM-300X

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