- The FDA has approved Purdue Pharma's Hysingla (hyrdocodone bitartrate), an ER opioid analgesic for severe, around-the-clock pain that cant' be controlled in other ways.
- Hysingla has a built-in abuse-deterrence feature which is activated when the drug is chewed, crushed, broken, or dissolved.
- Hysingla's safety and effectiveness was evaluated in a trial of 905 people.
Concern about opioid abuse has driven the development of analgesics that are more difficult to to take recreationally. This intense drug-development effort makes sense in light of the fact that prescription opioid abuse kills more Americans each year than cocaine and heroin combined, and leads to 420,000 trips to the hospital annually.
This is the third approval of an opioid painkiller with built-in abuse deterrence in the last four months, including Purdue's Targiniq ER (naloxone oxycodone), which was approved in July, and Pfizer's Embeda (morphone/naloxone). Zogenix has also filed a supplemental NDA for an addiction-fighting version of its controversial pain pill Zohydro.