LONDON, Dec. 19 /PRNewswire-FirstCall/ -- SkyePharma PLC (Nasdaq: SKYE;
LSE: SKP) welcomes the publication of a new study in the December 2003 issue
of "Managed Care Interface" showing that patients with depression who were
prescribed controlled-release paroxetine (GlaxoSmithKline's Paxil(R) CR) were
less likely to discontinue therapy than patients receiving immediate-release
selective serotonin reuptake inhibitors (SSRIs). Paxil(R) CR, a modified
version of GlaxoSmithKline's SSRI antidepressant Paxil(R), incorporates
SkyePharma's Geomatrix(TM) oral controlled release delivery technology.
Paxil(R) CR was designed to reduce the incidence of nausea, the most common
side-effect of SSRI antidepressants, especially in patients initiating
therapy. Paxil(R) CR has been available in the US market since April 2002 and
SkyePharma receives a royalty on GlaxoSmithKline's sales. In the three months
ending 30 September 2003, sales of Paxil(R) CR were 110 million pounds
Sterling ($177 million), representing 30% of the US Paxil(R)/Paxil(R) CR
franchise total.
The database study looked at more than 80,000 patients in managed care
organizations across the United States and found that patients taking
controlled-release paroxetine were 28 percent less likely to discontinue
therapy during a 180-day period than patients taking immediate-release SSRIs.
American Psychiatric Association (APA) treatment guidelines recommend that
patients with depression remain on antidepressant therapy for a minimum of six
months. However more than 40 percent of patients discontinue treatment within
the first 90 days.
The clinical benefit of increased length of treatment is well-documented,
indicating that depression and/or anxiety relapses are less likely with
patients who remain on therapy longer. A decrease in relapse rates could
substantially reduce the current costs associated with this disease in
America, which currently total in excess of $80 billion annually. Previously-
published clinical trial data(1) shows that controlled-release paroxetine is
associated with improved tolerability and a lower adverse event drop-out rate
as compared with immediate-release paroxetine, suggesting a rationale for the
extended treatment duration of patients taking controlled-release paroxetine.
"With controlled-release paroxetine, more patients remain on therapy
during the critical maintenance-phase period than with immediate-release
SSRIs, enhancing the quality of depression management," said Dr. Quentzel,
Chief of Primary Care Psychiatry at Beth Israel Medical Center in New York,
NY. "Controlled-release paroxetine offers primary care physicians and mental
health providers an encouraging option to help reduce treatment
discontinuation."
The study examined claims data obtained from the PharMetrics Integrated
Outcomes Database, including data from 61 different managed care
organizations, encompassing more than 36 million lives and nearly 1 billion
claims. Patients were required to be at least 18 years of age and to have six
months of enrolment before their index date, defined as the date of the first
SSRI prescription. Only patients experiencing new therapy with SSRIs between
April 1, 2002 and December 31, 2002 were included in the study. A total of
82,337 patients were eligible for study inclusion. Most patients had
prescriptions for sertraline (Pfizer's Zoloft(R)), followed by immediate-
release paroxetine (GlaxoSmithKline's Paxil(R), now also available
generically), citalopram (Forest Laboratories' Celexa), and fluoxetine (Eli
Lilly's Prozac(R), now also available generically). Eight percent of eligible
patients received controlled-release paroxetine (GlaxoSmithKline's Paxil(R)
CR).
In the time-to-discontinuation analysis, patients were deemed to have
discontinued therapy when more than 15 days beyond the days' supply elapsed
between prescriptions. The discontinuation analysis indicated that patients
receiving controlled-release paroxetine were 28 percent less likely to
discontinue therapy as compared with patients receiving immediate-release
SSRIs. Furthermore, during the 180-day follow-up period, patients receiving
controlled-release paroxetine were 16.5 percent less likely to switch or
augment therapy as compared with patients receiving immediate-release SSRIs.
"Not only does non-compliance in antidepressant therapy make it more
difficult to effectively treat patients, but early therapy change or
discontinuation also places a financial burden on the health system." said
investigator Timothy Regan, Senior Manager with Applied Health Outcomes, the
outcomes research firm that conducted the study. "The improvements in length
of therapy seen with controlled-release paroxetine are expected to yield
substantial economic and clinical benefits for patients and managed care
organizations."
(1) Golden et al., J. Clin. Psychiatry, 63:7 (July 2002)
About SkyePharma
SkyePharma develops pharmaceutical products benefiting from world-leading
drug delivery technologies that provide easier-to-use and more effective drug
formulations. There are now nine approved products incorporating three of
SkyePharma's five technologies in the areas of oral, injectable, inhaled and
topical delivery, supported by advanced solubilisation capabilities. For more
information, visit http://www.skyepharma.com .
About Geomatrix(TM)
Geomatrix(TM) controlled release systems control the amount, timing and
location of drug release into the body. This is achieved by constructing a
tablet with two basic components: a core containing the active drug or drugs,
and one or two additional barrier layers that control the drugs' diffusion out
of the core. Tablets with a wide range of predictable and reproducible drug
release profiles can be made by combining different chemical components in the
core and barrier layers, each with a different rate of swelling, gelling and
erosion.
About Managed Care Interface
Managed Care Interface, launched in 1988, is a monthly peer-reviewed
journal for the US managed care industry. Each month, Managed Care Interface
publishes fully refereed articles in a broad spectrum of interest, including
Pharmacy Practice, Pharmacoeconomics, Disease Management, and Health Care
Policy.
Except for the historical information herein, the matters discussed in
this news release include forward-looking statements that may involve a number
of risks and uncertainties. Actual results may vary significantly based upon a
number of factors, which are described in SkyePharma's 20-F and other
documents on file with the SEC. These include without limitation risks in
obtaining and maintaining regulatory approval for existing, new or expanded
indications for its products, other regulatory risks, risks relating to
SkyePharma's ability to manufacture pharmaceutical products on a large scale,
risks that customer inventory will be greater than previously thought, risks
concerning SkyePharma's ability to manage growth, market a pharmaceutical
product on a large scale and integrate and manage an internal sales and
marketing organization and maintain or expand sales and market share for its
products, risks relating to the ability to ensure regulatory compliance, risks
related to the research, development and regulatory approval of new
pharmaceutical products, risks related to research and development costs and
capabilities, market acceptance of and continuing demand for SkyePharma's
products and the impact of increased competition, risks associated with
anticipated top and bottom line growth and the possibility that upside
potential will not be achieved, competitive products and pricing, and risks
associated with the ownership and use of intellectual property rights.
SkyePharma undertakes no obligation to revise or update any such forward-
looking statement to reflect events or circumstances after the date of this
release.
SOURCE SkyePharma PLC
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Related links:
http://www.skyepharma.com
CONTACT:
Michael Ashton, Chief Executive Officer, or
Peter Laing, Director of Corporate Communications,
+44-207-491-5124, or Sandra Haughton, US Investor Relations,
+1-212-753-5780, all of SkyePharma PLC, +44-207-491-1777; or Tim
Anderson or Mark Court, both of Buchanan Communications,
+44-207-466-5000, for SkyePharma PLC
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