To contact us Click HERE
Forest
Laboratories (NYSE: FRX) announced that single doses of inhaled
aclidinium produced a significant bronchodilatory response in 17 patients
with COPD according to results of a phase IIa trial presented today at the
European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
Results of the study showed that mean FEV1 and FVC values - important
measures of lung function - were significantly increased with all studied
doses of aclidinium over a 24-hour time period, as compared to placebo.
Onset of significant bronchodilation was observed as early as 15 minutes
after aclidinium treatment and this effect was sustained for at least 24
hours. Forest licensed aclidinium, currently in phase III clinical trials
in COPD, from Spanish pharmaceutical company, Almirall.
Aclidinium was well-tolerated during the phase IIa trial and no
patients withdrew from the study because of adverse events. The majority of
adverse events reported were mild to moderate in intensity. The most
frequent drug- related adverse event observed was headache, which occurred
after both placebo and aclidinium treatment and was not dose-related.
Single doses of aclidinium did not result in any clinically significant
adverse effect on vital signs, heart function (as assessed by 12-lead ECG)
or laboratory data.
"Given the increasing disease burden of COPD in the US, there is a need
for new treatment options for patients suffering from this debilitating
disease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer. "These phase II data reinforce our belief that
aclidinium has the potential to be a significant addition to the existing
armamentarium of COPD treatments."
Methodology
The phase IIa study of aclidinium was a two-center, double-blind,
randomized, ascending single-dose, placebo-controlled, cross-over trial
which enrolled 17 patients with moderate to severe COPD. Treatment was with
one of three doses of aclidinium (100 micrograms, 300 micrograms or 900
micrograms) or placebo-administered via dry-powder inhaler. The study's
primary outcome measure was area under the normalized curve (AUC) of FEV1
over a 24-hour time period.
Findings of a phase I single-dose study, also presented at ERS 2007,
demonstrate the bronchodilatory effects of aclidinium.(2) In the phase I
study, in 12 healthy volunteers, bronchoconstriction was induced with
methacholine challenge and then treated with one of three doses of
aclidinium. Aclidinium proved superior to placebo in improving specific
airway conductance. Aclidinium also provided statistically significant and
sustained protection against methacholine-induced airway constriction over
24 hours. Aclidinium was well-tolerated throughout the trial. Headache was
reported by two subjects and one subject experienced a serious adverse
event which was not considered to be related to study drug.
Results of preclinical studies also presented at the congress show
aclidinium's selectivity, long duration of action and rapid clearance from
the plasma.(3,4) When compared to other bronchodilatory agents in vitro,
aclidinium demonstrated potent anticholinergic activity comparable to both
tiotropium and ipratropium, but with a faster onset of action than
tiotropium and a significantly longer duration of action versus
ipratropium, allowing for 24- hour duration of action.(4)
About COPD
COPD is a preventable and treatable lung disease characterized by
chronic airflow limitation that is not fully reversible.(5) COPD is a
leading cause of death, illness, and disability in the United States, with
an estimated 10 million to 24 million adults in the US living with COPD.(6)
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic bronchodilator
that is currently in phase III clinical development as a once-daily
maintenance treatment for COPD.
About Forest Laboratories and Its Products
Forest Laboratories (frx) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar
HCT(R) (olmesartan medoxomil - hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product, each indicated for the
treatment of hypertension; and Campral(R) (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2007 and quarterly report
on form 10-Q for the period ended June 30, 2007.
References
1. Joos GF, Schelfhout VJ, Kanniess F et al. Bronchodilator effects of
aclidinium bromide, a novel long-acting anticholinergic, in COPD
patients: a phase II study. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
2. Schelfhout VJ, Joos GF, Gil EG et al. Bronchodilator/bronchoprotective
effects of aclidinium bromide, a novel long-acting anticholinergic: a
phase I study. European Respiratory Society (ERS) Annual Congress,
September 2007. Poster.
3. Gavalda A, Miralpeix M, Ramos I et al. Aclidinium bromide, a novel
muscarinic receptor antagonist combining long residence at M3 receptors
and rapid plasma clearance. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
4. Miralpeix M, Gavalda A, Morcillo E et al. Assessment of the potency and
duration of action of aclidinium bromide in guinea pig isolated trachea
in vitro. European Respiratory Society (ERS) Annual Congress, September
2007. Poster.
5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy
for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease; MCR Vision, Inc.; 2006
6. CDC, cdc/nceh/airpollution/copd/copdfaq.htm, accessed
September 11, 2007.
Forest Laboratories
frx
View drug information on Benicar; Campral.
Hiç yorum yok:
Yorum Gönder