Astellas is currently conducting clinical trials of Qutenza including a Phase 3 trial to assess its use in the treatment of pain associated with PDN. Under the terms of the agreement, Acorda will have rights to review data from that trial, and the companies may also collaborate and/or share costs of future clinical trials.Postherpetic Neuralgia (PHN) or Post-Shingles Nerve Pain Postherpetic neuralgia (PHN), also known as post-shingles nerve pain, is chronic pain resulting from shingles, a viral infection caused by the same virus that causes chickenpox. There are approximately one million new cases of shingles in the United States each year. Shingles is characterized by an outbreak of rash or blisters on the skin and nerve pain that typically resolves within several weeks. However, up to one-third of people who have a shingles outbreak experience PHN, which can continue for months or years after the shingles rash has healed. About Painful Diabetic Neuropathy (PDN) Diabetes is a group of diseases marked by high levels of blood glucose resulting from defects in insulin production, insulin action or both. According to the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK), more than 23 million people in the U.S. have diabetes. Painful diabetic neuropathy is a common complication of diabetes characterized by chronic pain that results from damage to nerves due to poor circulation and high blood sugar. People with diabetes can develop nerve problems at any time, but risk rises with age and longer duration of diabetes. Diabetic neuropathies also appear to be more common in people who have problems controlling their blood glucose, as well as those with high levels of blood fat and blood pressure, and those who are overweight. Qutenza Important Safety Information Qutenza ® is indicated for the management of neuropathic pain associated with postherpetic neuralgia. Treatment with Qutenza must be performed only by a healthcare provider. You should never apply or remove Qutenza yourself. Warnings and Precautions:
- Qutenza is not for use near eyes or mucous membranes. Do not sniff or inhale near the Qutenza patch as this may cause you to cough or sneeze.
- Do not touch the Qutenza patch with your hands. If you touch the patch, it may cause burning and stinging; if this occurs, tell your healthcare provider.
- Even though a numbing medicine is used on the skin before applying Qutenza, some patients may still experience substantial pain during the treatment. Tell your healthcare provider if you are experiencing pain; a cool compress or medicine for the pain can be provided to help lessen your discomfort.
- Qutenza can cause serious side effects including pain and increases in blood pressure during or right after treatment.
- Your healthcare provider should check your blood pressure during treatment with Qutenza.
- Patients who have high blood pressure that is not well controlled by medicine, or who have had recent heart problems, stroke, or other vascular problems, may be at increased risk and should discuss with their doctor whether Qutenza is right for them.
- In clinical studies, the most common drug-related side effects of Qutenza, which occurred in 5% or more of patients, included redness, pain, small bumps, and itching. These side effects occurred at the patch application site.
- You should tell your doctor if any side effects bother you or do not go away.
Acorda Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including our ability to successfully market and sell Ampyra in the U.S.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including Diazepam Nasal Spray or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market Diazepam Nasal Spray or other products under development; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaboration partner Biogen Idec in connection therewith; competition, including the impact of generic competition on Zanaflex Capsules revenues; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; failure to comply with regulatory requirements could result in adverse action by regulatory agencies; and the ability to obtain additional financing to support our operations. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities & Exchange Commission. Acorda may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this release are made only as of the date hereof, and Acorda disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this release.