FDA approval and launch of OxyContin

The Food and Drug Administration’s late-1995 approval of OxyContin gave Purdue Frederick a new product just as the patent on its earlier painkiller was nearing expiration. The company launched the reformulated oxycodone drug the following year with ambitions beyond hospice and end-of-life care. Its arrival became a consequential turning point in the book’s account of the modern opioid epidemic: a medicine promoted for a wide range of pain, even though its own approval materials described risks associated with crushing and injecting it.

A company seeking its next painkiller

Purdue Frederick was little known when the Sackler brothers bought it in 1952 from its original Manhattan owners. The small company had only a few employees and annual sales of $20,000. Its new owners first made their fortunes with over-the-counter products, including laxatives, earwax remover, and Betadine, the antiseptic used to wash down the Apollo 11 spacecraft after its mission to the moon. International expansion followed in the 1970s, including the acquisition of Scottish and British drug companies.

The company entered pain relief with MS Contin, a morphine-derived medication for end-of-life pain developed in 1984. By the mid-1990s, its annual sales had reached $170 million, but the product had run much of its profit-making course as its patent approached expiration. OxyContin was brought forward to fill that commercial gap. It was a reformulation of oxycodone, a compound first developed in 1917 and synthesized from thebaine, an ingredient in the Persian poppy.

Approval and a wider intended market

Approved in late 1995, OxyContin was not intended to remain limited to hospice and terminal care. Purdue promoted it for chronic pain more broadly, presenting prescribing it as appropriate not only for people dying of cancer but also for patients with moderate injuries and common conditions. The drug’s delayed-release design was central to its appeal: the claim that absorption over time reduced the potential for abuse helped support the case for wider use.

That confidence sat uneasily beside information in the drug’s approval record. The 1995-filed application reviewed by Curtis Wright described how crushing the tablets could release the drug immediately rather than in a controlled manner. It also recorded withdrawal symptoms in several clinical-trial participants and reported that 68 percent of the oxycodone in one crushed tablet could be recovered when the material was liquefied and injected. The approval materials therefore contained specific warnings about risks that the public-facing assurances of controlled release could obscure.

Launch, promotion, and early warning signs

Purdue’s marketing arm, Purdue Pharma, managed promotion and sales. David Haddox promoted OxyContin for many kinds of chronic pain and told the company’s expanding sales force that addiction rates were below 1 percent. Sales representatives carried the message to doctors and dentists in all fifty states, framing prescribing the drug as responsible and compassionate treatment—not only for terminal illness but also for moderate back injuries, wisdom-tooth surgery, bronchitis, and temporomandibular joint disorder.

Early signs of abuse appeared soon after the drug’s release. In one Virginia town, the most experienced drug detective alerted a pharmacist to the problem only a couple of months after launch; people were already appearing with shirts stained by the drug’s colored coating. The pharmacist already doubted the company’s claim that delayed absorption reduced abuse liability. These reports stood in contrast to Purdue’s later position that it had not known of OxyContin’s abuse problems until February 2000.

A turning point in a longer history

The book sets OxyContin’s arrival against a history in which warnings about powerful drugs repeatedly receded from public memory. By the late 1990s, a new wave of opioid addiction was spreading through doctors’ prescriptions and developing into a broader epidemic involving heroin, despite accumulated medical expertise, regulatory initiatives, and the War on Drugs. The approval and launch did not alone account for that crisis, but the drug’s intended reach, its confident promotion, and the risks already present in its approval record form a central part of the account of how it began.