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Alkermes, Inc. (NASDAQ: ALKS) announced that the Food and Drug Administration (FDA) has asked Alkermes’ partner, Johnson & Johnson Pharmaceutical Fact-finding & Development, L.L.C. (J&JPRD), in the course of additional information regarding the supplemental New Drug Request (sNDA) for RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection). The sNDA, submitted in April 2008, sought approval into RISPERDAL CONSTA in compensation adjunctive support treatment to delay the happening of mood episodes in patients with bipolar disorder who relapsed regularly.
The Agency’s intact response outlined questions that poverty to be addressed till to granting approval for the additional indication, but did not request additional studies.
J&JPRD is currently evaluating the FDA’s complete response letter and compel work with the Agency to resolve any outstanding questions.
Bipolar disorder is a brain disorder that causes bizarre shifts in a person’s keen, drive and ability to function. It is time after time characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression), and affects 5.7 million, or 2.6 percent, of the American grown up population in any understood year.1
RISPERDAL CONSTA is marketed in the U.S. by Janssen®, Segmentation of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL CONSTA was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes’ proprietary Medisorb® drug-delivery technology, the RISPERDAL CONSTA formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a spa water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to make therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two certainly occurring compounds that are then eliminated by the heart.
RISPERDAL CONSTA is second-hand for the treatment of schizophrenia.
Important Sanctuary Facts Because Risperdal® Consta®
Elderly Patients with dementia-interrelated psychosis treated with atypical antipsychotic drugs are at an increased risk of ruin compared to placebo. RISPERDAL® CONSTA® ((risperidone) Extensive-Acting Injection) is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially calamitous side less reported with RISPERDAL® CONSTA® and similar medicines. Ring up your doctor immediately if the himself being treated develops symptoms such as high-priced fever; compact muscles; shaking; confusion; sweating; changes in thrumming, sensibility rate, or blood require; or muscle wound and weak point. Treatment should be stopped if the person being treated has NMS.
Tardive Dyskinesia (TD) is a precarious, sometimes permanent side effect reported with RISPERDAL® CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The hazard of developing TD and the bet that it intent become immutable is thought to growth with the length of psychotherapy and the overall quantity taken by the patient. This condition can develop after a brief span of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or lock if therapy is stopped.
Extravagant blood sugar and diabetes sire been reported with RISPERDAL® CONSTA® and like medications. If the person being treated has diabetes or jeopardize factors such as being overweight or a family yesteryear of diabetes, blood sugar testing should be performed at the origination and everywhere in treatment with RISPERDAL® CONSTA®. Complications of diabetes can be serious and nonetheless life threatening. If signs of steep blood sugar or diabetes develop, such as being thirsty all the convenience life, going to the bathroom a heaps, or fervour weak or avid, contact your doctor.
RISPERDAL® CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a teach known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued manoeuvre. Some side effects seen with these medications count the absence of a menstrual epoch; breasts producing milk; the development of breasts by males; and the inability to win an erection. The correlation between prolactin levels and side effects is unknown.
Some people taking RISPERDAL® CONSTA® may feel faint or lightheaded when they subscribe to up or sit up too apace. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.
RISPERDAL® CONSTA® may wear your alertness or driving ability; consequence, do not drive or control machinery before talking to your healthcare professional.
RISPERDAL® CONSTA® should be hardened cautiously in people with a seizure melee, who have had seizures in the past, or who have planned conditions that widen their risk for seizures.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you keep holy any of these symptoms, talk to your healthcare professional.
Blab on your healthcare professional if you ripen into eloquent or intend to become pregnant during treatment with RISPERDAL® CONSTA®. Caution should be exercised when RISPERDAL® CONSTA® is administered to a nursing woman.
RISPERDAL® CONSTA® may insist upon you more sensitive to heat. You may have go to the trouble cooling substandard, or be more likely to become dehydrated, so take feel interest when exercising or when doing things that make you warm.
Some medications interact with RISPERDAL® CONSTA®. Please inform your healthcare trained of any medications or supplements that you are taking. Escape alcohol while on RISPERDAL® CONSTA®.
In a study of people engaging RISPERDAL® CONSTA®, the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
If you have any questions about RISPERDAL® CONSTA® or your cure, talk with your doctor.
About Alkermes
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients’ lives. Alkermes developed, manufactures and commercializes VIVITROL® for alcohol dependence and manufactures RISPERDAL® CONSTA® against schizophrenia. Alkermes’ robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, lasting diseases, such as main nervous organization disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research facilities in Massachusetts and a commercial manufacturing karzy in Ohio.
Certain statements off forth above may constitute bold-looking statements within the meaning of the Unofficial Securities Legal remedy Reform Act of 1995. Although the convention believes that such statements are based on intelligent assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company’s matter is subject to relevant hazard and uncertainties and there can be no self-possession that its actual results liking not differ materially from its expectations. These risks and uncertainties include, among others, the ability of Alkermes’ partner to respond to the FDA crown response and the ultimate decisions by the FDA relating to the sNDA in compensation RISPERDAL CONSTA on account of adjunctive livelihood treatment in patients with bipolar disorder. For besides information with respect to factors that could provoke the company’s actual results to differ materially from expectations, reference is made to the reports the Company filed with the Securities and Return Commission under the Securities Argument Skit of 1934, as amended. The forward-looking statements made in this story are made solitary as of the old hereof and the company disclaims any intention or responsibility in the interest of updating predictions or financial expectations contained in this publicity release.
Medisorb is a registered trademark of Alkermes, Inc., VIVITROL is a registered trademark of Cephalon, Inc. and RISPERDAL CONSTA is a registered trademark of Janssen-Cilag.
1 Kessler RC, Chiu WT, Demler O, Walters EE. Currency, spareness, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun;62(6):617-27.
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