Drug maker Javelin hopes to meet with the Food and Drug Administration (FDA) to discuss approval of its new painkiller, Ereska. The drug is a non-opioid nasal medication designed to treat moderate to severe pain and provide physicians with an accepted and regulated alternative to off-label use and opioids.
Ereska is a formulation of ketamine, an anesthetic and analgesic that is also known on the streets as a “date rape” drug. It is well positioned to compete against Cephalon’s opioids Actiq and Fentora for breakthrough pain in cancer patients who have built up a resistance to opioids.
A 2007 study found Cephalon’s painkillers were most often used for the treatment of migraines and backaches, a use that is not approved by the FDA and found to cause serious adverse events in patients who have not already built up a tolerance to opioids. Javelin hopes Ereska will serve as an FDA-approved alternative for doctors and their patients seeking treatment for pain.
The world of painkillers is especially treacherous for drug makers, who have to tackle issues of narcotics abuse and safety issues with their products. Off-label use of Actiq and the more potent Fentora have been linked to fatal respiratory complications and associated with 127 deaths and 91 incidences of severe side effects.
Javelin’s Ereska may serve as a safer alternative; however, it isn’t foolproof. Phase III clinical trials for Ereska showed myriad hallucinatory and other psychomimetic effects in healthy volunteers taking sub-anesthetic doses of the drug, an issue that raises safety concerns among pain specialists.
Source: Behavioral Health Central