FDA approves first nonopioid drug for opioid withdrawal symptoms
The U.S. Food and Drug Administration approved the drug Lucemyra, a medication meant to mitigate withdrawal symptoms from opioid abuse in adults, officials announced Wednesday. It is the first nonopioid treatment to be approved to assist opioid withdrawal symptoms.
The treatment is approved for up to 14 days and officials warned that while it may lessen the severity of withdrawal, it might not completely prevent them, officials said.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction," said FDA Commissioner Scott Gottlieb, M.D., in a statement. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that’s sometimes associated with the use of medication-assisted treatments.” (Release)
State will appeal judge’s decision that overturned California’s physician aid-in-dying law
A state judge overturned the law that took effect in 2016 that allows physicians to prescribe medications to terminally ill patients who want to end their lives, but the judge gave the California attorney general five days to file an emergency appeal to keep the law in place. California Attorney General Xavier Becerra said in a statement emailed to the Los Angeles Times that his office would appeal the ruling. (FiercePracticeManagement)
New Jersey healthcare executives charged with more than $300M fraud
The former executives of a now-defunct health technology company are facing criminal charges for what prosecutors are calling an “elaborate” fraud scheme that bilked investors out of more than $300 million. The criminal complaint was filed Wednesday by the U.S. Attorneys Office in New Jersey.
Former CEO of Constellation Healthcare Technologies, Inc., Parmjit “Paul” Parmar, along with former Chief Financial Officer Sotirios “Sam” Zaharis and Executive Director Ravi Chivukula, were charged with orchestrating a scheme to defraud an investment firm in a go-private transaction.
Federal prosecutors alleged the executives created fictitious companies that Constellation allegedly acquired, then falsified bank records for those companies along with fake customer accounts to make it appear the company brought in more revenue than it did. As part of the go-private transition, one private investment firm based in New York sunk $82 million into the company and a consortium of financial lenders added $130 million in loans. (Complaint) (FierceHealthIT)