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Ulrike Jahnke is a senior editor on the Cortellis Forecast team. She has more than 10 years of experience in the pharmaceutical industry, drafting critical reviews about the competitive pharmaceutical landscape, writing news alerts, SWOT analyses, conference reports, market insights and feature articles. Ulrike has a PhD in Oncology and a 1st Class Honours degree in Biochemistry.

The 2018 Drugs to Watch report, the annual industry forecast and analysis from Clarivate Analytics published in March, forecast 12 new drugs to enter the market in 2018 and achieve blockbuster sales of $1 billion or more by 2022. In a follow-up series we have reviewed the status and landscape of each expected blockbuster with the last in the series being Indivior’s Sublocade, a once-monthly formulation of buprenorphine for opioid dependence. To date, all forecast drugs have either already been launched or have been approved, with anticipated blockbuster status unchanged. Concluding the follow-up series and supporting our predictions, peak sales for Sublocade, which in March 2018 had Cortellis Consensus Sales Forecasts (source Thomson Reuters I/B/E/S) of $1,072 billion, remain expected at more than $1 billion.1

“To date, all forecast drugs have either already been launched or have been approved, with anticipated blockbuster status unchanged.”

Opioid addiction is a chronic disease and was declared a public health emergency in late 2017 by the U.S. government.2 Regular use of opioids, including pain relievers available legally by prescription, such as oxycodone, hydrocodone and codeine, the illegal drug heroin and synthetic opioids such as fentanyl, can lead to dependence and, when misused, opioid pain relievers can lead to overdose and death.3 Effective medications exist to treat opioid use disorders including methadone, buprenorphine and naltrexone, but available treatments have limitations. Launch of Sublocade in March 2018 as the first monthly injectable buprenorphine has potential to disrupt the market for medication-assisted treatment options to overcome opioid use.4

The current standard of care for medication-assisted treatment is oral buprenorphine taken daily, with Indivior’s Suboxone (buprenorphine and naloxone sublingual tablet) leading the market. However, Suboxone use is limited by the burden and inconvenience of daily dosing, which can contribute to low compliance and suboptimal outcomes; self-administration also makes those treatments susceptible to diversion. Other options include Braeburn Pharmaceuticals/Titan’s Probuphine, a six-month subcutaneous sustained-release buprenorphine implant formulation which is placed with a minor in-office surgery, potentially introducing risks associated with surgical procedures such as infection. Additionally, Alkermes’s once-monthly and non-narcotic naltrexone formulation Vivitrol is disadvantaged by its requirement for a detox period prior to the first injection.5

“Launch of Sublocade in March 2018 as the first monthly injectable buprenorphine has potential to disrupt the market for medication-assisted treatment options to overcome opioid use.”

Sublocade addresses the limitations of existing treatment options. It is administered via subcutaneous injection once a month by a healthcare provider and does not require a detox period. In a phase III trial, patients with opioid use disorder who were treated with Sublocade had significantly higher abstinence rates than those receiving placebo (42.7% versus 5.0%).6 Presence of opioids in urine samples and self-reported opioid use were also lower among patients given Sublocade versus those given placebo.7

A couple of challenges remain for Sublocade. Another long-acting, subcutaneous buprenorphine formulation, Braeburn’s CAM-2038, is currently under regulatory review in the U.S. and EU with potential approval at the end of 2018.8,9 While Sublocade requires initiating treatment with an oral buprenorphine product for at least seven days until dose stabilization10, CAM-2038 does not have this requirement, can be titrated for tailored, personalized treatment and can be administered either weekly or monthly.11 CAM-2038 is thus posing a direct threat to Sublocade although complementary use with induction on CAM-2038 followed by maintenance on Sublocade is an option.

“Sublocade addresses the limitations of existing treatment options.”

Additionally, Indivior has seen slow initial Sublocade uptake due to inefficiencies associated with the prior authorization process across payors, leading to frustrations among patients and healthcare professionals. However, the prescription journey time has been reduced in the months following launch and, with encouraging anecdotal feedback and in view of the opioid crisis in the U.S., the opioid use disorder market is likely to undergo conversion driven by newer treatments including Sublocade.1,12

Figure 1: Blockbuster drug predictions at the time of the 2018 Drugs to Watch report. Source: Thomson Reuters I/B/E/S.