WASHINGTON, March 16 /PRNewswire/ -- Two studies sponsored by Dura
Pharmaceuticals, Inc. (Nasdaq: DURA) on behalf of Spiros Development
Corporation II, Inc. (Nasdaq: SDCOZ) presented at the American Academy of
Allergy, Asthma and Immunology (AAAAI) annual meeting poster session concluded
that Albuterol Spiros(R) 140 mcg (albuterol sulfate) Inhalation Powder,
delivered using Dura's Spiros(R) proprietary investigational inhaler,
demonstrated a safety profile comparable to Ventolin(R) Inhalation Aerosol
(albuterol, USP) metered dose inhaler (MDI) in patients with asthma, and
showed similar efficacy to Ventolin(R) MDI during nocturnal bronchospasm in
patients with asthma. The results of these studies are currently under review
by the U.S. Food and Drug Administration (FDA) as part of the Companies'
request for marketing approval.
The Spiros(R) Inhaler uses a unique, breath-activated technology and is
designed to deliver a consistent dose of drug to the lungs independent of a
patient's ability to inhale forcefully. By eliminating the press-and-breathe
technique, the product requires minimal patient coordination. Additionally,
Spiros(R) requires no chloroflourocarbon (CFC) or other propellants.
"With the increasing rate of asthma, there is a growing need for delivery
systems that allow patients to receive a consistent dose of medication with
minimal inhalation effort," said James P. Kemp, M.D., of the Allergy and
Asthma Research Center in San Diego. "I am excited about these study results
because we anticipate that Albuterol Spiros(R) will offer patients several
advantages over products currently on the market."
These advantages address the limitations of other inhalation delivery
systems, such as MDIs and dry powder inhalers. MDIs are currently the most
commonly used method of delivering asthma medications in the U.S., but most
contain CFC propellants, which deplete the ozone layer and are subject to
worldwide regulations aimed at eliminating their use. Additionally, MDIs
generally require press-and-breathe coordination that many patients are unable
to properly perform.
The first study, presented by James Kemp, M.D., et al., involved a
comparison of Albuterol Spiros(R) to Ventolin(R) MDI in 283 subjects with
asthma between the ages of 12 and 79. The subjects received two actuations,
four times a day in a randomized, double-blind and placebo controlled
protocol. The investigators concluded that this study demonstrated that
albuterol delivered via the Spiros(R) Inhaler and Ventolin(R) MDI were
comparable in safety for patients with moderate asthma.
Leslie Hendeles, Pharm.D., of the University of Florida, presented the
second study, which evaluated the dose-response of inhaled albuterol during
nocturnal bronchospasm. The dose-responses of albuterol delivered via the
Spiros(R) and Ventolin(R) MDI were compared in 37 subjects between the ages of
18 and 45 during nocturnal bronchospasm. The study was randomized and single
blind. Subjects slept in a research center on two nights and received one,
two, four and eight cumulative actuations of albuterol at 25 minute intervals.
Each product was administered on a different night. The investigators'
analysis showed that albuterol delivered via the Spiros(R) Inhaler and
Ventolin(R) MDI were therapeutically comparable during severe nocturnal
bronchospasm.
A one-year open label study is in progress to collect data on long-term
patient use of the Albuterol Spiros(R) system. Data from this study, along
with data from the other pivotal studies, must be reviewed by the FDA prior to
final marketing approval. Albuterol Spiros(R) is expected to be the first
multi-dose non-CFC albuterol powder inhaler product available in the U.S.
Market launch is planned for late 1998 or early 1999, pending FDA approval.
Dura Pharmaceuticals, Inc., is a San Diego-based developer and marketer of
prescription pharmaceutical products for the treatment of allergies, asthma
and related respiratory conditions. Dura has focused on the U.S. respiratory
market because of its size and growth opportunities through two major
strategies: (1) acquiring respiratory prescription pharmaceuticals and/or
businesses developing or marketing such pharmaceuticals targeted at high-
prescribing respiratory physicians, and (2) developing Spiros(R), a pulmonary
drug delivery system.
Spiros Development Corporation II, Inc. is a separate public company
formed primarily to fund the continued development of Spiros(R), a proprietary
pulmonary drug delivery system, and to conduct formulation work, clinical
trials and commercialization for defined asthma drugs in the Spiros(R)
Inhalation System.
Except for the historical or factual information contain herein, the
matters discussed in this press release may contain forward-looking statements
which involve risks and uncertainties, including the timely development of the
Spiros(R) system, government regulation and dependency on FDA approval,
competitive products, Dura's and Spiros Development Corporation II, Inc.'s
limited manufacturing experience, dependency on third parties and their
successful development efforts, and other risks detailed from time to time in
the companies' filings with the Securities and Exchange Commission. Actual
results may differ materially from those projected. Forward-looking
statements represent the companies' judgments as of the date of this release.
Each of Dura and Spiros Development Corporation II, Inc. disclaims, however,
any intent or obligation to update any forward looking statements.
SOURCE Dura Pharmaceuticals, Inc.
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CONTACT: Karen Lundstedt, Director, Investor Relations, Dura Pharmaceuticals, 619-457-2553
CNOC: http://www.prnewswire.com or fax, 800-758-5804, ext. 197051
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