Opioid use disorder (OUD) is a chronic neurological disorder characterised by the compulsive, repeated use of opioid drugs, leading to prolonged self-administration.

Opioid agonists dominate the treatment landscape for OUD, but their use is marked by a risk of “diversion” — the illicit use of opioid medications — meaning that their dispensing is often restricted to specialised treatment programmes. Furthermore, concerns over the safety of opioid agonists persist, particularly full agonists such as methadone, which have been associated with a higher risk for fatal arrhythmias. The issues surrounding opioid medications have led to a significant push in developing non-opioid medications that treat addiction and withdrawal, but the competition from existing opioid medications is strong and finding a non-opioid to match their efficacy is proving to be challenging.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

In November 2024, AstraZeneca terminated its development of an OUD drug, AZD4041, after the orexin 1 receptor antagonist demonstrated a drug-drug interaction with an antifungal during a Phase II trial (NCT06406400). The two-part study had been evaluating the drug-drug interactions of AZD4041 in healthy volunteers to determine the optimal dose for the randomised, placebo-controlled, double-blind portion of the trial. This was to be conducted in healthy participants and aimed to assess AZD4041’s potential as an adjunctive treatment to the approved OUD agonist drug buprenorphine.

AstraZeneca confirmed that the programme was discontinued after the pharma identified a “potential drug-drug interaction” with itraconazole, which is FDA-approved to treat serious fungal or yeast infections such as a fungal lung infection called histoplasmosis and certain types of candidiasis. The failure of the trial highlights the challenges in developing non-opioid medications that treat addiction and withdrawal.

Opioid agonist therapies to drive sales of $1.75 billion by 2033

According to GlobalData’s Drug Database, six out of the seven agents currently in late-stage development (Phases IIb and III) are non-opioids. This includes a cannabinoid product, a PPARγ agonist, a sodium-dependent dopamine transporter inhibitor, an androgen receptor antagonist and a pannexin-1 inhibitor. Aside from Jazz Pharmaceuticals’ Epidyolex, which has published Phase II outcomes in a study evaluating its efficacy as an adjunct treatment to patients on opioid agonist therapy (NCT04567784), there is a distinct lack of efficacy data at this time for the other pipeline agents mentioned. Furthermore, the aforementioned treatments are expected to enter the market as adjunctive treatments to the existing first-line therapies, so they would not likely displace methadone or buprenorphine as first-line treatments for OUD.

GlobalData forecasts that opioid agonist therapies could drive combined sales of $1.75 billion by 2033 in Australia, Canada, France, Germany, Italy, Spain, the UK and the US, and make up 83.8% of the global OUD market. Such market dominance is emblematic of the lack of an alternative to opioid agonist therapies, but also of patient preference, which plays a key role in OUD treatment.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Opioid use is the natural tendency of an OUD patient

Key opinion leaders (KOLs) previously interviewed by GlobalData have spoken at length about the autonomy patients living with OUD have over their treatment. KOLs stated that methadone and buprenorphine are well-recognised by OUD sufferers: they are effective, and it would be difficult to develop a therapy that would be able to challenge these two. One KOL has described OUD as a “relapsing-remitting disorder,” in that the natural tendency of an OUD patient is to use opioid drugs. By framing OUD through that lens, it is no surprise that non-opioid medications are only being investigated as adjunctive therapies to existing opioid treatments. There is an underlying acceptance that the opioid pathway is the only viable pathway in the treatment of OUD.

The failure of another non-opioid therapy for the treatment of OUD is disheartening, and the OUD treatment landscape is bereft of an effective non-opioid therapy to challenge the existing opioid agonists. Although opioid agonists are the gold standard for the treatment of OUD, they have not been able to solve the opioid crisis. Conversely, the non-opioid agents currently being developed are only under investigation as adjunctive therapies and are marred by a lack of efficacy data, leaving KOLs understandably skeptical over their prospects as OUD treatments. As a result of the stagnating treatment landscape, GlobalData expects that any non-opioid product with a strong efficacy and safety profile for the treatment of OUD would likely see strong uptake and disrupt the OUD market.