Toronto Stock Exchange Symbol: DND

    MISSISSAUGA, ON, May 13 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals
Inc. (TSX: DND) today announced that a revised New Drug Application (NDA)
has been submitted to the U.S. Food and Drug Administration (FDA) for
CIP-TRAMADOL ER, its extended-release formulation of tramadol. In May 2007,
the Company received an approvable letter from the FDA pertaining to its
NDA for CIP-TRAMADOL ER.

    Cipher's revised NDA includes data from additional pharmacokinetic
studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.

    After considering feedback from the FDA appeal process and the results
of the additional statistical sensitivity analysis of existing data
suggested by the FDA, Cipher and its advisors concluded that submitting the
revised NDA provided the most expeditious path to final regulatory
approval.

    Subject to FDA acceptance for filing, Cipher expects the review to be
completed by October 2008. It is possible that the submission could trigger
patent infringement litigation and a stay of up to 30 months under the
Hatch-Waxman Act.

    About Cipher Pharmaceuticals Inc.

    Cipher Pharmaceuticals is a drug development company focused on
commercializing novel formulations of successful, currently marketed
molecules using advanced drug delivery technologies. Cipher's strategy is
to in-license products that incorporate proven drug delivery technologies
and advance them through the clinical development and regulatory approval
stages, after which the products are out-licensed to international
partners. Because Cipher's products are based on proven technology
platforms applied to currently marketed drugs, they are expected to have
lower approval risk, shorter development timelines and significantly lower
development costs. The Company's lead compound, CIP-FENOFIBRATE, received
final approval from the U.S. Food and Drug Administration and Health Canada
in the first quarter of 2006. The product is being marketed in the United
States by ProEthic Pharmaceuticals under the label Lipofen(R). In addition,
Cipher is developing formulations of the pain reliever tramadol (FDA
approvable letter in May 2007) and the acne treatment isotretinoin (FDA
approvable letter in April 2007).

    Cipher is listed on the Toronto Stock Exchange under the symbol 'DND'
and has approximately 24 million shares outstanding. For more information,
please visit http://www.cipherpharma.com.

    Forward-Looking Statements

    Statements made in this news release, other than those concerning
historical financial information, may be forward-looking and therefore
subject to various risks and uncertainties. Some forward-looking statements
may be identified by words like "may", "will", "anticipate", "estimate",
"expect", "intend", or "continue" or the negative thereof or similar
variations. Certain material factors or assumptions are applied in making
forward-looking statements and actual results may differ materially from
those expressed or implied in such statements. Factors that could cause
results to vary include those identified in the Company's Annual
Information Form and other filings with Canadian securities regulatory
authorities, such as the applicability of patents and proprietary
technology; possible patent litigation; regulatory approval of products in
the Company's pipeline; changes in government regulation or regulatory
approval processes; government and third-party payer reimbursement;
dependence on strategic partnerships for product candidates and
technologies, marketing and R&D services; meeting projected drug
development timelines and goals; intensifying competition; rapid
technological change in the pharmaceutical industry; anticipated future
losses; the ability to access capital to fund R&D; and the ability to
attract and retain key personnel. All forward-looking statements presented
herein should be considered in conjunction with such filings. The Company
does not undertake to update any forward-looking statements; such
statements speak only as of the date made.

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