nobogart
04-22-2005, 01:39 PM
Sativex-Maker Hires Former Drug Czar Deputy Director
Salisbury, United Kingdom: Health Canada granted regulatory
approval
this week to Sativex, an oral spray consisting of natural cannabis
extracts, for the treatment of neuropathic pain associated with
Multiple
Sclerosis. The spray is expected to be available to the Canadian public
by
prescription later this spring.
Produced by the British biotechnology firm GW Pharmaceuticals,
Sativex
is a whole plant medicinal cannabis extract containing precise doses of
the cannabinoids THC and cannabidiol (CBD), as well as naturally
existing
terpenoids (oils) and flavonoids (antioxidants). In clinical trials,
Sativex has been demonstrated to alleviate numerous MS-associated
symptoms
compared to placebo, including pain, muscle spasms, and bladder
incontinence.
"This event marks the world's first approval of a [natural]
cannabis-derived medicine," said GW Pharmaceuticals Executive Chairman
Geoffrey Guy. The company, along with its partner Bayer AG, is
expected
to begin negotiations with the Food and Drug Administration later this
year regarding opportunities to bring Sativex to the US market.
GW is expected to seek further approval from Health Canada to
market
Sativex for additional therapeutic indications. Recent clinical trials
on
Sativex found that it significantly reduced pain in cancer patients
compared to placebo, and relieved urinary dysfunction in patients
suffering from advanced Multiple Sclerosis.
Although regulatory approval for Sativex in the United Kingdom
remains
pending, an advisory body of the British Medicines and Health products
Regulatory Agency (MHRA) announced in December that it required further
clinical evidence of Sativex's ability to alleviate MS-associated
spasticity in a "clinically relevant" manner before the agency would
consider approving the drug for licensing in the UK.
GW Pharmaceuticals also announced this week that it had hired
former
White House Drug Czar Deputy Director Andrea Barthwell in an advisory
capacity. As Deputy Director, Barthwell lobbied against legislative
efforts to legalize the medical use of whole smoked cannabis by
qualified
patients. "Having this product (Sativex) available will certainly slow
down the dash to make the crude plant material available to patients
across the country," Barthwell told the Los Angeles Times Wednesday.
Responding to Barthwell's statement, NORML Executive Director Allen
St. Pierre, said, "We are pleased that Sativex may one day offer a
legal
option for US patients and physicians. However, patients who choose to
use whole smoked cannabis therapeutically under their doctor's
supervision
should not have to live in fear of arrest or incarceration for using
their
chosen medication."
For more information, please contact either Allen St. Pierre or
Paul
Armentano of NORML at (202) 483-5500.
Salisbury, United Kingdom: Health Canada granted regulatory
approval
this week to Sativex, an oral spray consisting of natural cannabis
extracts, for the treatment of neuropathic pain associated with
Multiple
Sclerosis. The spray is expected to be available to the Canadian public
by
prescription later this spring.
Produced by the British biotechnology firm GW Pharmaceuticals,
Sativex
is a whole plant medicinal cannabis extract containing precise doses of
the cannabinoids THC and cannabidiol (CBD), as well as naturally
existing
terpenoids (oils) and flavonoids (antioxidants). In clinical trials,
Sativex has been demonstrated to alleviate numerous MS-associated
symptoms
compared to placebo, including pain, muscle spasms, and bladder
incontinence.
"This event marks the world's first approval of a [natural]
cannabis-derived medicine," said GW Pharmaceuticals Executive Chairman
Geoffrey Guy. The company, along with its partner Bayer AG, is
expected
to begin negotiations with the Food and Drug Administration later this
year regarding opportunities to bring Sativex to the US market.
GW is expected to seek further approval from Health Canada to
market
Sativex for additional therapeutic indications. Recent clinical trials
on
Sativex found that it significantly reduced pain in cancer patients
compared to placebo, and relieved urinary dysfunction in patients
suffering from advanced Multiple Sclerosis.
Although regulatory approval for Sativex in the United Kingdom
remains
pending, an advisory body of the British Medicines and Health products
Regulatory Agency (MHRA) announced in December that it required further
clinical evidence of Sativex's ability to alleviate MS-associated
spasticity in a "clinically relevant" manner before the agency would
consider approving the drug for licensing in the UK.
GW Pharmaceuticals also announced this week that it had hired
former
White House Drug Czar Deputy Director Andrea Barthwell in an advisory
capacity. As Deputy Director, Barthwell lobbied against legislative
efforts to legalize the medical use of whole smoked cannabis by
qualified
patients. "Having this product (Sativex) available will certainly slow
down the dash to make the crude plant material available to patients
across the country," Barthwell told the Los Angeles Times Wednesday.
Responding to Barthwell's statement, NORML Executive Director Allen
St. Pierre, said, "We are pleased that Sativex may one day offer a
legal
option for US patients and physicians. However, patients who choose to
use whole smoked cannabis therapeutically under their doctor's
supervision
should not have to live in fear of arrest or incarceration for using
their
chosen medication."
For more information, please contact either Allen St. Pierre or
Paul
Armentano of NORML at (202) 483-5500.