Posted by ed_uk on June 10, 2005, at 12:52:09
In reply to Sativex - an cannabis based medicine, posted by ed_uk on June 10, 2005, at 12:47:38
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
SATIVEX Qs and As
1. What is Sativex?
Sativex is a mouth spray containing a combination of two cannabis extracts,
indicated as “Add on therapy for symptomatic relief of spasticity in patients
with multiple sclerosis who do not respond adequately to other anti-spasticity
medication”.2. Why is Sativex in the news?
The Licensing Authority (UK Health Ministers) has decided against the grant
of a licence for Sativex at this stage. This follows the advice of the Medicines
Commission, an independent advisory body to the Licensing Authority.3. Why has the Medicines Commission advised against giving Sativex a
licence?
The Medicines Commission carefully reviewed all the evidence provided by
the company including patient testimonials. However, this was not considered
sufficiently compelling to meet the rigorous standards of efficacy required for
a UK product licence.4. What evidence would be considered satisfactory to license Sativex?
There are no hard and fast rules for establishing efficacy. However, there
needs to be evidence of benefit of clinical relevance in the patient population
under study, in this case in spasticity which is a long term complication of
multiple sclerosis. The benefits of any treatment must outweigh the potential
risks.5. What is spasticity?
Spasticity is a condition seen in a number of diseases including multiple
sclerosis. Patients tend to complain of stiffness, pain or discomfort, weakness
or spasms.6. Is Sativex safe?
No medicine is totally risk free. A range of possible side effects associated
with Sativex were reported in clinical trials, including dizziness, somnolence,
weakness, fatigue and confusion. If convincing evidence of efficacy can be
provided, the side effect profile would not preclude a favourable balance of
risks and benefits.7. When will Sativex be granted a licence in the UK?
Clinical trials with Sativex are currently under way in multiple sclerosis
patients. It is not possible at this stage to predict when there will be sufficient
evidence to support the grant of a licence.8. Isn’t Sativex already available in Canada?
The Canadian Drug Regulatory Authority, Health Canada, has granted an
“approval with conditions” for Sativex. There are significant differences
between the criteria required for what has been proposed in Canada for
Sativex as opposed to the current UK system.
poster:ed_uk
thread:510581
URL: http://www.dr-bob.org/babble/20050606/msgs/510583.html