Tackling the global crisis of addiction is not a labour for the faint-hearted. Rising levels of drug use are barbed with the complexities of opioid dependence and wreathed with the unpredictable wildfires of lawsuits.
The opioid crisis resulted in an alarming spike in premature deaths in the US – 130 fatalities a day attributed to opioid-related overdoses at one stage – and has focused attention on how Europe will cope with advancing issues.
Four major pharmaceutical companies recently agreed to pay $260m to settle the first wave of actions in the US, with some experts predicting final bills of around $50bn across the industry.
It is hardly the easiest climate in which to market an opioid-based drug to treat addiction, while at the same time developing new treatments, but Indivior, the British-based firm that was part of Reckitt Benckiser until 2014, is undaunted.
Its share price took a massive hit when it was indicted by the US Justice Department earlier this year over its Suboxone Film therapy for opioid and heroin addiction, but its robust response, more of which later, has not deflected its mission to create safe and effective drugs to deal with, rather than inflame, a crisis.
The company’s mantra ‘Addiction is a treatable chronic condition, not a moral failure’ is sustaining its R&D work and Gilles Picard (pictured above), its head of global strategy and European operations, said the company is close to new registrations in Europe for opioid addiction products.
“We don’t use that as a slogan; it is what we believe,” he said. “We aim to change people’s lives with treatments for addiction and we are pleased to see that, in recent years, more people are of the view that addiction is a chronic condition and not some moral failing.
High success rate
“We also believe that over the next few years many more people will have access to opioid addiction therapies. But we need societal change as well as drug development and it is clear that some countries have better established routes to treatment than others.
“Opioid agonist treatment is scientifically underpinned and has a high success rate. The figure I use is 70-60-50. It reduces the mortality risk by 70%, lowers the risk of hepatitis C infection by 60% and has a 50% lower risk of relapse. Not many addiction treatments can produce those figures.”
European healthcare structures are better constructed to deter an opioid crisis from reaching US proportions, with stricter marketing regulations, stronger prescribing rules and a more open and progressive approach to opioid agonist therapy and other forms of harm reduction acting as effective gatekeepers.
But it could do more, argued Picard, and improving access was a theme explored in detail at Lisbon Addictions in October 2019, which focused on new frontiers of policy, practice and science.
Access to healthcare in heightened risk groups where people have low self-esteem and do not seek treatment, combined with stigmatising methods of controlled supervision and reduced funding for support services, are hindering the take-up of opioid addiction therapies, said Picard.
“Many countries, including the UK, favour controlled supervision of opioid agonist treatment on the pretext of limiting misuse when there is no strong evidence that daily supervision at the pharmacy improves outcomes,” he added. “But access to safer medicines has shown you can reduce mortality, HIV infection and relapse while also limiting misuse to a low percentage.
“Europe is set up differently to the US but we are seeing increases in drug-related deaths from powerful painkillers. They are up 41% in England, albeit from a very low base, while the rate of drug-related deaths in Europe is around 22 per million people compared to the US at 240 deaths per million.
Stigma busting
“Europe is not exposed to such huge dramatic levels but we need to continue to widen access to treatments. They reach about 50% of those people who need them in England but the levels of access to treatment in other countries, such as the Nordic and Baltic states, are much lower.
There is no reason why such an effective treatment should not reach coverage levels of 65-85% as they do in France, Switzerland and Belgium which experience lower rates of drug-related deaths.”
Indivior discovered buprenorphine, sold it under the brand name Subutex to treat opioid addiction in 1996 and has since expanded its portfolio with Suboxone tablets, Suboxone Film, the monthly injectable Sublocade for opioid addiction, and the long-acting injectable Perseris for schizophrenia in adults, which got FDA approval this year.
Its R&D focus is on six main neuronal pathways in the brain that are compromised by repeat and prolonged exposure to psychoactive substances.
It is in preclinical studies that target receptor proteins in the central nervous system, and the most advanced compound, orexine-1 antagonist should enter human trial next year. The portfolio covers all addictions and has an ambition to remove the stigma from medication dosing and dispensing.
“We have always tried to develop drugs that are more efficient or improve access to treatments that are easier to administer to patients; the injectable buprenorphine version delivers a constant level of buprenorphine that addresses the three drivers of addiction – withdrawals, craving and positive reinforcement – and also removes the need for daily supervision,” said Picard.
“We believe it is one step further in the recovery journey of the patient.”
Pipeline provides hope
Indivior is fighting the Department of Justice charges ‘vigorously’ and a company statement accused the US Justice Department of pursuing ‘self-serving headlines on a matter of national significance’.
It added that Indivior conducts approximately 75% of all private research into opioid addiction, stating: ‘No other company has done more to fight the opioid crisis and we continue to be fully dedicated to helping patients, doctors and communities dealing with opioid addiction.’
Dealing with the indictment requires attention and resource, but Picard believes the pipeline proves that R&D is not being deflected.
He added that the launch of Perseris underscores the ethos of making medication easier for vulnerable communities, as it can be administered by monthly injections rather than the complicated dosing schedules of other drugs that can make it difficult for schizophrenia patients to trust and adhere to regimes.
“We have always had the philosophy of gathering as many patient insights as we can when developing drugs,” he said.
“I’m excited about the future and, although there is a lot of work to be done to improve access and availability, we can make a difference and I believe that over the next five years there will be many more patients with access to opioid addiction therapies – that is our prime goal.”
Danny Buckland is a journalist specialising in the healthcare industry