According to a New York Times article the pharmaceutical company involved in the drug's development was Zogenix, a specialty pharmaceutical company based in San Diego.
Dr. Deborah McMahan, Allen County health commissioner, said, “The real question is why has the FDA approved something that their panel of advisors voted 11-2 against?”
McMahan agreed with Zoeller; the question is why, when the United States already has a prescription drug-addiction problem, does the FDA need to approve a drug that is prescribed in pills ranging from 10 milligrams to as high as 50 milligrams? Zoeller said in his news release that current hydrocondone products only range from 5 to 10 milligrams.
“I am definitely against its release,” McMahan said.
McMahan said the drug is in a pill form that can be crushed for snorting or injection. It is designed for people with chronic pain. She questioned why the drug would be designed with no built-in safeguards when the ability to accidentally overdose is so high. McMahan said between 2008 and 2013 in Allen County there were 270 accidental drug overdoes of patients on prescription drugs.
The only benefit of the drug is that it contains no acetaminophen, McMahan said, which keeps people from damaging their livers in the event of an accidental overdose.
To lessen prescription drug overdose in Indiana, Zoeller set up the Indiana Prescription Abuse Prevention Task Force. The group involves state legislators, law enforcement, medical representatives, health officials, pharmacists, state and local agencies and education providers. In 2013 the task force started a statewide prescription-abuse awareness campaign. McMahan is the leader of the task force, and Dr. Daniel Roth, of the Summit Pain Management, is a member of the group who serves on the education committee.
Roth, whose medical group works to help people control chronic pain, said his group will not prescribe the drug, not because it is so powerful, but because it has no built-in safeguards to prevent abuse. Other drugs that are equally as powerful have preventative measures that keep a substance abuser from isolating the pure drug by dissolving or crushing the capsule.
“There are 10-15 other drugs already on the market that have abuser safeguards that I could prescribe for patients which provide the same level of pain reduction as Zohydro ER offers,” Roth said.
If the drug was injected into someone in pure form or the user took a very high-dose pill without a built-up tolerance, it could kill him or her. The biggest risk, Roth said, is if someone other than the designated patient, for example a 20-year old grandchild, takes it to get high.
Roth explained with a patient under doctor care there are a number of required safety measures under state regulation that a doctor must follow to ensure patients really need the drug, and then to monitor patients to make sure they are not abusing it.
Nationally, Sen. Joe Manchin (D-W. Va) introduced a bill March 13 to withdraw the FDA approval for the painkiller. In a news release from Manchin's office he said he has repeatedly requested the FDA to change its approval of the drug. Its refusal to do so had forced him to introduce the legislation. The bill would withdraw FDA approval of the drug unless it is “reformulated” to prevent abuse.