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News (Media Awareness Project) - US MA: Drug Has No 'Buzz'
Title:US MA: Drug Has No 'Buzz'
Published On:2003-10-08
Source:Worcester Telegram & Gazette (MA)
Fetched On:2008-01-19 10:05:15
DRUG HAS NO 'BUZZ'

WORCESTER- A drug invented by a local researcher and based on a compound in
marijuana relieved pain in patients without generating a "high," according
to a study published last week.

The results should silence concerns that ajulemic acid, the key drug
ingredient, might not be a safe, effective treatment, said Sumner H.
Burstein, a professor in the University of Massachusetts Medical School
department of biochemistry and molecular pharmacology.

"We've put to rest a lot of the doubters, people that question the
psychoactivity problem," said Mr. Burstein.

The study, published last week in the Journal of the American Medical
Association, reported results that were first publicized in December 2002
by Indevus Pharmaceuticals Inc. of Lexington, which has developed the drug
IP 751.

Researchers at Hannover Medical School in Hannover, Germany, gave the drug
to 21 patients who reported chronic pain as a result of spinal or
peripheral nerve injuries. Patients took the drug in varying doses, and
inactive substances, for two weeks and were evaluated for pain and mental
functioning.

Indevus and Atlantic Technology Ventures Inc., which first licensed the
rights to ajulemic acid, funded the trial. Indevus officials did not return
messages yesterday seeking comment on the study.

The researchers reported that patients experienced significant pain
reductions three hours after taking IP 751. The effects were weaker eight
hours after taking the drug, the researchers said.

In addition, people with milder pain experienced a more marked reduction in
pain than those patients with more severe pain, the researchers said.

Primary side effects were tiredness and dry mouth. Some patients reported a
loss of concentration, dizziness, sweating and pain.

None of those side effects were related to the chemical buzz that marijuana
can generate, Mr. Burstein said.

"There are many drugs that will produce mild tiredness, so I don't think
you can say it's a marijuana effect," Mr. Burstein said. "These patients
are under constant pain. They're not getting any relief ... When they get
relief from it, what do they feel? They relax and they feel tired."

IP 751 was developed from a metabolite of tetrahydrocannabinol, the
ingredient in marijuana that produces a high. Metabolites are substances
that the body produces as it processes a drug.

No part of IP 751 was extracted from marijuana, said Mr. Burstein. Instead,
the drug is synthetic, entirely manmade.

The drug seems to inhibit inflammatory cytokines, substances produced by
the body, such as interleukin-1 beta and TNF-alpha, according to Indevus.

The company has filed an application with the Food and Drug Administration
to test IP 751 in patients in the United States and wants to begin studies
next year, Indevus reported.
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