Maker of Marijuana-Based Prescription Painkiller Seeking FDA Approval

A British company named GW Pharma is seeking FDA approval to sell a marijuana-based prescription painkiller in the U.S.  The drug, which is administered as an oral spray and is intended for cancer patients, is the world’s first prescription drug that contains raw marijuana.  According to API reports, GW Pharma hopes to begin marketing the new drug, which it calls Sativex, in 2013.

sativexSativex contains the two most potent components in marijuana – cannabidiol and delta-9 THC.  GW Pharma lists the main benefits of the new drug as analgesic, anticonvulsant, antipsychotic, anti-spasmodic, anti-inflammatory and appetite stimulation.  The most common side effects are fatigue, dizziness, anxiety, confusion, rapid heartbeat, intoxication and depression.  Sativex has already been approved in 8 European countries as well as Canada and New Zealand for treatment of muscle spasms caused by multiple sclerosis.

Although 16 U.S. states and the District of Columbia have legalized the use of marijuana for medical reasons with a doctor’s recommendation, the federal Drug Enforcement Agency categorizes cannabis as a dangerous drug.  As recently as July of 2011, the DEA ruled that marijuana has no accepted medical use.  If Sativex is approved by the FDA, the federal government may have to come up with a unified position on the use of marijuana, especially since approval of Sativex will inevitably lead to the development of similar drugs by other pharmaceutical companies.

More than two decades ago, the FDA approved a synthetic versions of THC for use in two drugs.  These drugs, named Cesamet and Marinol, are sometimes prescribed to reduce the side effects of chemotherapy for cancer patients.  Marinol is also prescribed to stimulate the appetites of AIDS patients. Last year, the patents on these drugs expired and other companies are now reported to be developing a variety of drugs that use synthetic THC.

It is currently unknown whether a prescription painkiller that contains raw marijuana will be subject to the same type of abuse as is currently seen with other painkillers like OxyContin.  However, the official warning for Sativex states that the medication is not recommended for people who are subject to marijuana addiction since the drug can cause physical and psychological dependence and has the potential for abuse.  The Sativex literature also contains a long list of drugs that should not be taken at the same time, including alcohol, amphetamines, barbiturates and opioids.