TORONTO, Nov. 19, 2012 /CNW/ - Purdue Pharma Canada is deeply concerned
with today's statement from the federal Minister of Health that she may
not act to delay a decision on generic OxyContin.
The Minister states that she has heard from doctors and patients about
OxyContin's positive impact on the treatment of severe pain and that
the issue of prescription drug abuse is larger than one specific
product. We agree. But the Minister's own Scientific Advisory Panel
recommended in March 2011 that manufacturers introduce new opioids
which are less crushable and less abusable. This is why we introduced
The Minister refers to "insufficient proof" to back up claims that
OxyNEO, the replacement for OxyContin, is harder to abuse. We disagree.
In fact, published data from surveillance studies in the U.S., where
OxyNEO has been available for two years, has been submitted on a
regular basis and the most recent data submission is still under review
by Health Canada.
It shows significant decline in abuse and demand, including a lower
street price for the tablets as well as decreases in admissions to
addiction treatment and the number of adverse drug reactions reported
to poison control centres. There is also evidence of improved safety
for patients and their caregivers. We are disappointed that Health
Canada has not taken this important evidence into account.
The Minister indicates the law does not permit her to withhold approval.
On the contrary, under the Food and Drugs Act, the Minister must be
satisfied that any drug, including generics, meets safety and
effectiveness standards prior to issuing an approval.
A higher standard has been established with OxyNEO and it is one that
should now be applied to all new controlled-release oxycodone products,
including generics. As such, we urge the Minister to consider the
evidence and require any generic OxyContin to meet those standards in
the interest of public and patient safety.
About Purdue Pharma Canada
A research-based pharmaceutical company in Pickering, Ontario, Purdue
Pharma Canada (www.purdue.ca) is committed to improving patient health and well-being, by developing
innovative medicines and supporting quality education for the safe use
of its products.
SOURCE: Purdue Pharma
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