The numbers in the US alone are astonishing: more than 53,000 people over 12 months; an average of 146 a day. This is the death toll from opioid overdoses last year, many of them from widely prescribed painkillers, such as tramadol, codeine and oxycodone.
Donald Trump has declared America’s opioid problem a “public health emergency” as it spiralled into the deadliest drug epidemic in US history. Now the pharmaceutical industry, which has been heavily criticised for its role in the crisis, is seeking to address a disaster it helped create. Two companies are offering new monthly treatments for those hooked on powerful painkillers, with one approved by the US regulator last week.
London-listed Indivior, which was spun out of Reckitt Benckiser in 2014, has developed a medication that is injected into the belly fat once a month – the world’s first monthly treatment for opioid addiction. Sublocade contains buprenorphine, which was developed by Reckitt in Hull and takes away cravings without giving a high.
The new medication, which is set to hit the US market early next year, is designed to create a steady state in the patient without withdrawal symptoms (nausea, itching, the shakes), thereby reducing the chance of relapse while receiving counselling and support.
Indivior is also in talks with regulators in the UK, Australia, Canada, Sweden and Germany about having Sublocade approved. Paul Cuddon, analyst at stockbroker Numis, said: “Sadly, it is not a perfect cure, but does appear to significantly increase the abstinence rate in hard-to-treat patients. Coupled with psychosocial support and better awareness of the dangers of prescribing opioids, this epidemic can be brought under control.”
Elsewhere in the industry, another injectable treatment that can be given weekly or monthly has been developed by Swedish firm Camurus and licensed to private-equity-owned Braeburn Pharmaceuticals of the US. The advisory panel for the US Food and Drug Administration has recommended approval for some of the proposed doses, asking for more data on the higher doses. The regulator’s decision is due in mid-January. Braeburn says the medication can suppress patient withdrawals within an hour after the first dose.
Indivior and Braeburn are trying to tackle a massive problem. Almost 12 million adults misused opioids in the US last year and more than 2.5 million were diagnosed with opioid-use disorder; yet only 1.1 million received treatment. In England, the number of patients admitted to hospital for overdosing on opioid painkillers doubled in the past decade, to 11,660 last year. Opioid prescriptions doubled to 24 million in 2016, according to NHS Digital figures.
The Indivior and Braeburn drugs are an opportunity for the drug industry to atone for its aggressive push of opioids as the go-to medication for pain. It is facing a wave of litigation: a county in New York state has sued Purdue Pharma, Johnson & Johnson, Teva and Endo over their marketing of opioids. At least 30 lawsuits have been filed against doctors, pharmacists and drug wholesalers in West Virginia alone, which has the highest overdose death rate in the nation (and the second-highest unemployment rate).
Opioid overdoses have become the leading cause of death in Americans under 50 – four people are dying from them every hour. At the root of the crisis are overprescriptions of opioid painkillers – drugs derived directly from the opium poppy or made synthetically – for anything from cancer to severe back pain, arthritis and sports injuries. Aside from the human cost, the cost to the US economy was estimated at $504bn in 2015, and since then the crisis has worsened.
Shaun Thaxter, Indivior’s chief executive, said: “This is not the stereotyped, old-fashioned, out-of-date image of an injecting heroin user living on the street – we are talking about normal people from all levels of society.”
More than 34,000 people died in the US in 2016 after overdosing on synthetic opioids such as fentanyl and tramadol (almost 20,000 deaths), or natural and semi-synthetic painkillers including morphine, codeine and oxycodone (over 14,500 deaths). There were also more than 15,500 heroin and 3,400 methadone deaths, according to provisional government figures.
Fentanyl, a painkiller developed as a patch for cancer patients that is nearly 100 times stronger than morphine, has become one of the biggest killers. It is the drug that killed singer Prince; it is easy to make illicitly and cheap to buy on the street. Street heroin is increasingly laced with fentanyl. Shipped over from China, the synthetic opioid’s apt street names are Drop Dead and Murder 8 – a single pill can kill.
In Britain, at least 88 deaths have been linked to fentanyl since last December, up from 58 in 2016 and 34 in 2015. Victims include 18-year-old skateboarder Robert Fraser from Kent, who died last November. His mother, who has joined a near-1,000 strong Facebook group called Fentanyl Victims – We Remember, said she had never heard of fentanyl until she read the toxicology report.
Harry Shapiro, director of UK charity DrugWise, has been calling on the UK government to set up a helpline. He said: “It’s a public health issue hidden in plain sight. It’s got to run into hundreds of thousands of people. There are millions of prescriptions being written. We are swallowing an awful lot of these pills. It’s an issue for primary healthcare professionals [GPs] as much as for treatments down the line.”
However, cost could also be an issue. Sublocade will cost $1,580 per monthly dose. But the new medication is still expected to become a blockbuster; analysts at Jefferies are forecasting peak sales of $1.3bn by 2025.
America’s opioid crisis dates back to the 1990s, when healthcare organisations encouraged doctors to treat post-operative pain more aggressively. But then drug companies, led by the Sackler family’s firm Purdue Pharma, the maker of OxyContin, embarked on an aggressive push of opioid painkillers for all kinds of chronic pain, enticing doctors with freebies and all-expenses-paid trips. Opioid pills were soon sold in vast quantities through barely regulated treatment centres, which became known as “pill mills”.
Many more pharma companies will need to follow Indivior’s example if the industry is to silence its critics.