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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 2 of 2. This is the beginning of the thread.
Posted by ed_uk on June 10, 2005, at 12:47:38
Sativex turned down by UK licensing authority.........
PRESS RELEASE
Date: 10 June 2005
Time: 08:00 hrsSubject: Sativex appeal decision
Contact: Press Office 020 7084 3535 or press.office@mhra.gsi.gov.ukSATIVEX APPEAL DECISION
The Medicines and Healthcare products Regulatory Agency (MHRA) has today
confirmed that the Medicines Commission has turned down an appeal on the
licensing of Sativex in the UK by GW Pharmaceuticals. The application was for the
relief of spasticity in multiple sclerosis (MS).
The advice was given by the Medicines Commission following a hearing on 13 May
2005 and was this week accepted by the UK Licensing Authority.
GW Pharmaceuticals was appealing against advice given by the Committee on
Safety of Medicines (CSM) to the MHRA in December 2004 not to grant a licence for
Sativex in the UK. The CSM was not satisfied with the efficacy of Sativex in the
indication sought by the company. It is up to the company to provide relevant
supporting data to reassure CSM that the efficacy of the product is satisfactory and
that benefits outweigh risks.
Professor Kent Woods, Chief Executive of the MHRA, said: “We acknowledge that
this decision may cause disappointment to MS patients who have been waiting for
the outcome of this appeal. However, in this case there was insufficient evidence to
show that the risk-benefit relationship was favourable.”
Notes to Editor:1. There are approximately 60,000 people with MS in the UK. Around 400 patients in
the UK are currently being treated with Sativex under special provisions.2. Under the terms of a ‘conditional’ licence in Canada, Sativex has been used for
the relief of neuropathic pain in MS. However, the proposed clinical indications for
Sativex in Canada and in the UK are different and the Canadian regulatory
system allows for ‘conditional licensing’, for which there is no current UK
equivalent.3. The Medicines Commission considers appeals in cases where the Committee on
Safety of Medicines (CSM) has advised against the grant of a licence. The
Medicines Commission reports its findings and advice, and the reasons for its
advice, to the Licensing Authority (UK Health Ministers).4. In the UK, all new medicines, including Sativex, go through the process of gaining
a licence. Applications are considered by the MHRA, which obtains advice from
the CSM. Medicinal products can only be granted a licence when evidence has
been submitted to demonstrate that the overall risk benefit profile is satisfactory
within the context of the clinical indications proposed by the company.
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.
This is the end of the thread.
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