Zohydro, a pure hydrocodone pain pill, has just been approved for sale in the U.S. by the FDA. This pure hydrocodone pill will be classified as a Schedule II drug, much like Oxycontin and oxycodone, according to “Fox and Friends Weekend” on Sunday Oct. 27.
According to Bloomberg on Oct. 25, Hydrocodone is the narcotic pain medication found in pain pills like Vicodin, a name brand for hydrocodone and acetaminophen. The way this medication is now offered will be similar to the drug oxycodone, which is found combined with acetaminophen in drugs like Percocet, but is also sold as a standalone pain killer. Hydrocodone will now follow suit and be available as both, in a combination drug and now as a standalone drug.
Instead of combining hydrocodone with another drug, which is the only way it has been offered up until now, it can now be sold as a medication without any other ingredients. The patient will get just the pure pain medication in the new Zohydro pill from Zogenix, the manufacturer.
One of the concerns that that the FDA brings forth is the possibility of abuse with this drug by crushing it for snorting or dissolving it in water to be used for injecting the drug. This was a problem with the drug Oxycontin, but the manufacturer devised a new form of a pill that cannot be crushed to snort and it does not dissolve in water. When it gets wet, it turns into a gel-like substance.
The new hydrocodone pill won’t have that safeguard, so the FDA has asked Zohydro to study the drug’s abuse potential while it is on the market. The Drug Enforcement Administration is the agency that sets the schedule for the drug.
Right now the FDA has requested that the combination drugs that contain hydrocodone be reclassified from the Schedule III drug to a Schedule II, like the drug oxycodone. But the new hydrocodone pill will already be classified under the Schedule II drug when it hits the market.
Schedule II drugs are limited to a 90-day supply and patients must visit their doctor before they are prescribed more, as opposed to the five refills within six months for Schedule III drugs.
The new pure hydrocodone pill is suggested for use with patients who suffer with long-term pain. It is not a drug that should be prescribed for acute pain, according to the FDA.