Health Canada approves Actonel 75 mg - First and only monthly two-day dosing regimen to treat postmenopausal osteoporosis in Canada



    TORONTO, Aug. 28 /CNW/ - Health Canada recently approved Actonel(R)
(risedronate sodium tablets) 75 mg, the first and only monthly two-day dosing
regimen for the treatment of post-menopausal osteoporosis soon available for
use in Canada. With Actonel 75 mg, patients take one 75 mg tablet on two
consecutive days each month. This means a less frequent oral dosing option
will soon be available to Canadian osteoporosis patients. Such therapies are
currently available only in other countries.
    "Patients have been asking me for some time about a monthly dosing
regimen," says Dr. Alexandra Papaioannou, Professor of Medicine, McMaster
University. "Until now, Canadian osteoporosis patients have had to take their
osteoporosis medications weekly or even daily. This new dosing regimen may
offer patients a convenient way to treat their osteoporosis and prevent
fractures. Actonel 75 mg may be appealing to newly diagnosed osteoporosis
patients at risk for fracture or those currently on daily osteoporosis
treatment regimens."
    Actonel 75 mg builds upon the proven vertebral and nonvertebral fracture
protection of Actonel for the treatment of postmenopausal osteoporosis and has
an overall safety profile similar to Actonel 5 mg daily(1). Actonel has been
shown to reduce the risk of vertebral(2,3) and nonvertebral fractures(2)
including those at the hip(4), and has been shown to reduce the risk of
fractures as early as six months(5,6,7). Early fracture protection means fewer
patients will suffer the potentially devastating effects of a fracture.
    "This new dosing regimen is a great option for people with osteoporosis,"
says osteoporosis patient Anne Wolf. "I don't like to take medication more
often than I have to, so to only have to take one pill two consecutive days a
month, while still protecting myself from fractures is very appealing."
    "The approval of a new dosing regimen is welcome news for the millions of
Canadians who have osteoporosis," says Julie Foley, President and CEO,
Osteoporosis Canada. "Osteoporosis is a debilitating disease that can take a
huge toll on those who suffer from it, their families, and our health care
system. It's vital that a range of treatment and dosing options are available
so patients can discuss with their physician the option that best suits them."
    With this recent approval, Actonel will be available in multiple dosing
options (5 mg daily, 35 mg Once-A-Week, and 75 mg monthly two day dosing
regimen) which allows physicians to help patients choose the option that best
meets their unique needs and lifestyle.

    About Osteoporosis
    ------------------
    Osteoporosis is a skeletal disorder characterized by compromised bone
strength predisposing a person to an increased risk of fracture. Bone strength
reflects the integration of two main features; bone density and bone
quality(8). Osteoporosis Canada reports approximately 1.4 million Canadians
suffer from osteoporosis. It affects one in four women over the age of 50(9).
Osteoporosis has important public health and clinical consequences because it
leads to fractures that commonly occur at the spine, wrist or hip. Fractures
can result in increased pain, disability, and mortality.
    A 50-year old woman has a 40 per cent chance of developing hip, vertebra
or wrist fractures during her lifetime(10). The lifetime risk of hip fracture
is greater (one in six) than the one in nine lifetime risk of developing
breast cancer(11). Patients are at highest risk for subsequent fracture in the
first few months following a vertebral fracture(12). One in four women who
have a new vertebral fracture will fracture again within one year(13).

    About Actonel
    -------------
    ACTONEL (risedronate sodium) is indicated for the treatment and
prevention of osteoporosis in post-menopausal women (PMO) for the treatment of
osteoporosis in men to improve bone mineral density, for Paget's disease, and
for the treatment and prevention of glucocorticoid-induced osteoporosis (GIO)
in men and women. Musculoskeletal pain, rarely severe, has been reported as a
common adverse event in patients who received ACTONEL for all indications. In
PMO and GIO studies with ACTONEL, the most commonly reported adverse reactions
were abdominal pain, dyspepsia and nausea. In patients with Paget's disease,
diarrhea and headache were also commonly reported(1). Please refer to Product
Monographs(1,14) for full dosing instructions, contraindications and warnings
and precautions.
    The approval of Actonel 75 mg is based on an active-controlled,
double-blind clinical trial of 1,229 postmenopausal women with osteoporosis
aged 50 years or older with a lumbar spine bone mineral density (LS BMD)
T-score less than or equal to -2.5 OR a LS BMD T-score less than or equal to
-2.0 and at least one prevalent vertebral fracture. In the trial, increases in
bone mineral density (BMD) at the lumbar spine, total hip, and hip trochanter
in patients treated with Actonel 75 mg, taken on two consecutive days a month,
were similar to those in patients treated with Actonel 5 mg daily at both time
points measured (six and 12 months). Both treatments were generally well
tolerated with adverse events between the two groups being similar.

    About The Alliance for Better Bone Health
    -----------------------------------------
    The Alliance for Better Bone Health was formed by P&G Pharmaceuticals and
Aventis, part of the sanofi-aventis Group, in May 1997 to promote bone health
and disease awareness through numerous activities to support physicians and
patients around the globe.

    About P&G (NYSE:  PG)
    -------------------
    Three billion times a day, P&G brands touch the lives of people around
the world. The company has one of the strongest portfolios of trusted,
quality, leadership brands, including Pampers(R), Tide(R), Always(R),
Pantene(R), Mach3(R). Bounty(R), Pringles(R), Swiffer(R), Folgers(R),
Charmin(R), Downy(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R),
Olay(R), Clairol Nice 'n Easy(R), Herbal Essences(R), Head & Shoulders(R),
Gillette(R), and Braun. The P&G community consists of almost 140,000 employees
working in over 80 countries worldwide. P&G is the leading consumer products
company in Canada with over $2.7 billion in annual sales. P&G Pharmaceuticals
is a division of P&G Health Care with products such as Actonel(R),
Didrocal(R), Asacol(R), MacroBID(R), and Dantrium(R).

    About sanofi-aventis
    --------------------
    Sanofi-aventis is one of the world's leading pharmaceutical companies.
Backed by a world-class R&D organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular, thrombosis,
oncology, metabolic diseases, central nervous system, internal medicine, and
vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE:   SNY). In Canada, sanofi-aventis employs more than 1,000 people and is
headquartered in Laval, Quebec.

    
    References:
    -----------
    (1)  Procter & Gamble Pharmaceuticals Canada Inc. ACTONEL Product
         Monograph, Toronto, July 17, 2007
    (2)  Harris ST, Watts NB, Genant HK et al. Effects of risedronate
         treatment on vertebral and nonvertebral fractures in women with
         postmenopausal osteoporosis. JAMA 1999;282(14):1344-52.
    (3)  Reginster J-Y et al. Randomized trial of the effects risedronate on
         vertebral fractures in women with established postmenopausal
         osteoporosis. Osteop Int 2000;11:83-91.
    (4)  McClung, M.R., Geusens, P., Miller, P.D., Zippel, H., Bensen, W.G.,
         Roux, C., et al. Effect of risedronate on the risk of hip fracture
         in elderly women. N Engl J Med. 2001;344:333-40.
    (5)  Harrington JT, Ste-Marie LG, Brandi ML, et al. Risedronate rapidly
         reduces the risk for nonvertebral fractures in women with
         postmenopausal osteoporosis. Calcif Tissue Int 2004;74:129-135.
    (6)  Roux C, Seeman E, Eastell R, Adachi J, Jackson RD, Felsenberg D,
         Songcharoen S, Rizzoli R, Di Munno O, Horlait S, Valent D, Watts NB.
         Efficacy of risedronate on clinical vertebral fractures within six
         months. Curr Med Res Opinion 2004; 20(4): 433-439.
    (7)  Silverman SL, Watts NB, Delmas PD, Lange JL, Lindsay R.
         Effectiveness of bisphosphonates on nonvertebral and hip fractures
         in the first year of therapy: the risedronate and alendronate (REAL)
         cohort study. Osteoporos Int 2007; 18(1): 25-34.
    (8)  Osteoporosis prevention, diagnosis and therapy. NIH consensus
         statements 2000;17(1):1-45.
    (9)  Hanley DA, Josse RG. Prevention and management of osteoporosis:
         consensus statements from the Scientific Advisory Board of the
         Osteoporosis Society of Canada: 1. Introduction.
         CMAJ 1996;155:921-3.
    (10) Melton LJ III, Chrischilles EA, Cooper C, Lane AW, Riggs BL.
         Perspective: how many women have osteoporosis? J Bone Miner Res
         1992;7:1005-10.
    (11) Cummings SR, Black DM, Rubin SM. Lifetime risks of hip, colles', or
         vertebral fracture and coronary heart disease among white
         postmenopausal women. Arch Intern Med 1989;149:2445-8.
    (12) Johnell O, Oden A, Caulin F, Kanis JA. Acute and long-term increase
         in fracture risk after hospitalization for vertebral fracture.
         Osteoporos Int. 2001;12(3):207-14.
    (13) Lindsay R, Burge RT, Strauss DM. One year outcomes and costs
         following a vertebral fracture. Osteoporos Int. 2005; 16:78-85
    (14) Procter & Gamble Pharmaceuticals Canada Inc. ACTONEL PLUS CALCIUM
         Product Monograph, Toronto, September 18, 2006.
    





For further information:

For further information: Julie Holroyde, Hill and Knowlton Canada, Tel:
(416) 413-4625, Email: julie.holroyde@hillandknowlton.ca; Fiona Robinson, Hill
and Knowlton Canada, Tel: (416) 413-4737, Email:
fiona.robinson@hillandknowlton.ca; For medical inquiries please call
1-800-565-0814

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