Aimmune Therapeutics Inc. won the backing of members of the FDA’s Allergenic Products Advisory Committee during a meeting held to discuss whether or not safety and efficacy data support licensure of Palforzia (AR-101), the company’s oral immunotherapy to reduce the incidence and severity of allergic reactions to peanut.
The FDA is opening a public docket for comments on the development and evaluation of abuse-deterrent formulations of central nervous system stimulants. The agency also wants to know whether such products could help address public health concerns related to prescription stimulant misuse and abuse. To date, the FDA has only approved abuse-deterrent formulations of opioid painkillers. The scope of misuse and abuse, illness and death is different for prescription opioids than for prescription stimulants, according to the agency. In opening the docket, the FDA said it is specifically seeking comment on associated harms and unintended consequences, including the risk of developing an addiction to the stimulants and transitioning to abuse of illicit stimulants or other substances.