Cannabis Science Inc (fka CBIS)

[DouglasJH]

Seems that rescheduling is coming along too, once Sativex makes FDA approval the gate is open.

Sativex Makes Progress Worldwide, Including in US

By Julie Stachowiak, Ph.D., About.com Guide April 26, 2011

Sativex is a drug that contains two main compounds derived from marijuana, the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC). It controls involuntary muscle movements in people with multiple sclerosis (MS). It also has been shown to help with MS-related pain, spasticity and bladder dysfunction. It is sprayed into the mouth.

Sativex is currently in a Phase III trial in the US for treatment of cancer pain, which is a necessary step for receiving FDA approval. Once FDA approval is received for Sativex, it can be used off-label to help people with MS. (For more information on how this works, read What is "off-label" use of drugs and is it legal?)

Sativex is currently approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of multiple sclerosis spasticity.

The US license to Sativex is held by Otsuka Pharmaceutical Co. Ltd in the United States and to Bayer HealthCare AG in the UK and Canada. GW Pharmaceuticals has signed a deal to have Novartis (makers of Gilenya) market Sativex in parts of Asia, the Middle East, Australia, New Zealand and Africa, so is moving ahead in those markets.

What is "off-label" use of drugs and is it legal? :

By Julie Stachowiak, Ph.D., About.com Guide

Updated April 10, 2009

Question: What is "off-label" use of drugs and is it legal?
I always encourage everyone to do some research on all the drugs that they are taking to make sure that there are no interactions with other drugs you might be on, no contraindications to taking them that may apply to you, and what type of side effects to anticipate. People who look up their drugs on MedlinePlus.gov or other sites may be surprised to find that the symptom that the medication that has been prescribed to help is not listed anywhere on the drug's description, leading them to wonder if their doc is confused or a mistake has been made. Nope, your doc has decided to use a drug "off-label."

Answer: Off-label use of drugs means that the medication is prescribed for a use other than it was approved for by the Food and Drug Administration (FDA). Drugs approved for use in the United States must go through rigorous testing in the form of clinical trials in order for it to be legal for physicians to prescribe them. Clinical trials test drugs against certain symptoms or illnesses, usually in certain age groups, and FDA approval is for these specific problems in this age group.

Once drugs are approved by the FDA, they can be legally prescribed for any reason and to any person. It is up to the doctor to use their professional experience and knowledge, when deciding which drugs to use in patients.

While it is legal to prescribe drugs off-label, it is illegal to advertise them for uses other than those for which the received FDA approval.

Many drugs used to manage the symptoms of multiple sclerosis (MS) are used off-label. Some of these include:

* Tricyclic antidepressants, such as nortriptyline (Pamelor) and amitriptyline (Elavil) to treat neuropathic pain (labeled as antidepressants)
* Modanifil (Provigil) to treat MS-related fatigue (labeled as a drug to treat narcolepsy or to help shift workers adjust to their schedules)
* Carbamazepine (Tegretol, Carbatrol) to treat trigeminal neuralgia and bladder dysfunction (labeled as an anticonvulsant drug)
* Isoniazid (Nydrazid) to treat intention tremor in MS (labeled as an antibiotic used to treat tuberculosis)
* Ondansetron (Zofran) also to treat intention tremor (labeled as an antinausea drug)