FDA staff flags dosing risk with Collegium opioid painkiller

By Samantha Kareen Nair and Natalie Grover (Reuters) - Staff at the U.S. Food and Drug Administration warned on Wednesday of the risks of incorrect dosing of another experimental opioid painkiller, highlighting the agency's concern about drugs that can be highly addictive. The FDA staff said Collegium Pharmaceuticals Inc's experimental oral opioid painkiller, to be sold as Xtampza if approved, could be wrongly used as it is designed to be taken after eating to provide maximum relief. Typically, opioid painkillers are used with no regard to food intake. On Tuesday, the reviewers pointed to likely errors in administering Purdue Pharma LP's short-acting opioid painkiller as it is intended for use on an empty stomach. The FDA staff said Collegium's long-acting experimental oxycodone pill, if taken in the absence of food, could lead to insufficient pain control, which in turn could contribute to overdosing and misuse. (http://1.usa.gov/1MaT3GL) The abuse of opioids - a class of drugs that include heroin and prescription painkillers - has long been a concern. An overdose of prescription painkillers can produce euphoric highs, and even disrupt the parts of the brain that control breathing. Since 2011, prescription opioid abuse has been classified as an epidemic by the U.S. Centers for Disease Control and Prevention, which estimates that overdoses kill about 44 people in the United States every day. Collegium has proposed to make clear on the label that Xtampza, its lead drug in development, should only be taken after eating. But since the drug developer plans to market the product in 100‐count bottles only, instead of singly, instructions will unlikely reach people directly, the reviewers said. They concluded that Collegium's packaging design would be inadequate to eliminate the risk of an administration error. If the FDA determines that Xtampza's benefits outweigh its risks, the company should assess the effectiveness of its packaging in preventing incorrect use, they recommended. The staff review was published on the FDA's website on Wednesday ahead of a meeting on Friday of a panel of outside advisers who will recommend whether the drug should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so. The regulator has said it expects to announce its final decision by Oct. 12. Shares of Canton, Massachusetts-based Collegium, which is developing several abuse-deterrent products to manage chronic pain, fell about 10 percent to $13.32 in morning trade.