Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-05-03
2001-03-06
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S195110, C424S464000, C424S456000, C424S466000, C424S468000, C424S472000, C424S484000, C424S489000, C514S819000, C514S872000, C514S937000
Reexamination Certificate
active
06197329
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to novel nutritional anti-nausea compositions, anti-emetic compositions and methods of using the same to provide relief from nausea and/or vomiting. The present compositions are also nonteratogenic and are therefore highly useful to pregnant women.
2. Description of the Related Art
Nausea and vomiting are two of the most common symptoms of illness and are also commonly experienced as side effects of numerous medical treatments. Both nausea and vomiting are also commonly experienced as a result of various external factors (e.g., travel) and during various conditions (e.g., pregnancy). Nausea and vomiting can occur individually or in conjunction with one another.
A common cause of nausea and vomiting is motion sickness. Motion sickness typically occurs when humans are subjected to long-lasting external movement or transportation accompanied by unusual movements such as shaking, waving, atmospheric changes (e.g., flying in an airplane), great acceleration, and uneven road conditions, etc. Motion sickness is not viewed as a disease but as a physiological symptom complex wherein the symptoms experienced, of which nausea and vomiting are common, depend on the individual in question. When the individual experiences motion sickness in a work environment, i.e., truck drivers, air pilots, air craft staff members and the like, the potential for a disadvantageous and dangerous condition result. Such individuals are often required to exhibit high level concentration and intellect, and the presence of motion sickness symptoms can severely detract from their ability to do so.
Though experienced by a more limited number of individuals, the nausea and vomiting associated with chemotherapy drugs and radiation treatment is especially problematic. Cancer treatment drugs such as Cisplatinum, Streptozotocin, Cytoxan, Nitrogen Mustard and Ara-C are known to cause severe nausea and vomiting as side effects. The reason that cancer drugs cause nausea and vomiting is still under investigation. It is believed that the drugs stimulate and irritate specific key areas in the brain which results in nausea and vomiting. Individuals undergoing cancer treatments and experiencing these side effects may feel discouragement beyond that which is directly related to their cancer. The inability to eat normally or to alleviate nausea can lead to increased patient depression.
The Merck Manual
, 1281-87 (16th Ed. 1992).
Postoperative nausea and vomiting is one of the most common side effects, estimated to be experienced by 20% to 30% of patients, after undergoing anesthetic and surgical procedures. Coates, A., “On the receiving end-patient perception of the side-effects of cancer chemotherapy”,
Eur J Cancer Clin Oncol
, 19:203-208 (1983); See also, Cooper, et al., “The impact of cytotoxic chemotherapy-perspectives from patients, specialists and nurses”,
Eur J Cancer Clin Oncol
, 28A(suppl 1):S36-S38 (1992). Research shows the occurrence of postoperative nausea and vomiting to be from 25% to 55% following inpatient surgery and from 8% to 47% for outpatient procedures. Id.; See also, Laszlo, J., “Nausea and vomiting as major complications of cancer chemotherapy”,
Drugs
, 25(suppl 1):1-7 (1983); See also, Tortorice, et al., “Management of chemotherapy-induced nausea and vomiting”,
Pharmacotherapy
, 10:129-145 (1990). When questioned prior to surgery, patients are often more concerned about post-operative nausea and vomiting than post-operative pain, since they perceive that the nausea and vomiting will be more debilitating. Tonato, et al., “Methodology of antiemetic trials: a review”,
Ann Oncol
, 2:107-114 (1991); See also, Fauser, et al., “Therapeutic equivalence of single oral doses of dolasetron mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy,”
Eur J Cancer
, 32A(9):1523-1529 (1996).
Nausea and vomiting are also both common in early pregnancy. Cases can range in degree from mild to severe, and symptoms usually begin soon after the first missed period. Morning sickness, i.e., nausea and vomiting experienced during the first and second trimesters of pregnancy, is experienced by approximately half of all pregnant women, however it is particularly common in cases of multiple pregnancy and hydatidiform mole. Kousen, M., “Treatment of nausea and vomiting in pregnancy”,
Am Fam Physician
, 48:1279 (1993).
Hyperemesis gravidarum, i.e., persistent nausea and vomiting during pregnancy, can lead to a reduction in fluid and electrolyte levels, as well as a jeopardized nutritional status if the condition is not treated. The condition is characterized by prolonged and severe nausea and vomiting, dehydration, ketosis, and body weight loss. Other complications may include hyponatraemia, hypokalaemia, a low serum level, metabolic hypochloraemic alkalosis, ketonuria, liver function test abnormalities, abnormal thyroid function tests, and suppressed thyroid-stimulating hormone levels. Nelson-Piercy, C., “Treatment of nausea and vomiting in pregnancy. When should it be treated and what can be safely taken?”,
Drug Saf
, 19(2):155-64 (1998).
Nausea and vomiting can also be brought on by a variety of other causes such as reactions to certain types of odors or visual stimuli, psychological perceptions, allergic reactions, drug interactions and the like. Whatever the cause, the presence of a nauseated and/or emetic condition in an individual can be debilitating for the period during which it is experienced, and therefore numerous antiemetic and antinausea compositions and methods have been described.
Many generalized nausea and vomiting treatment compositions have been described. For example, Tyers et al., U.S. Pat. No. 5,578,628, describe tetrahydrocarbazolone derivatives which may be used for the prevention and treatment of nausea.
Lovgren et al., U.S. Pat. No. 4,786,505, describe a pharmaceutical preparation containing omeprazole for oral use and a method of affecting gastric acid secretion and providing gastrointestinal cytoprotective effect when using them.
Lovgren, U.S. Pat. No. 4,853,230, describes an easily water soluble pharmaceutical preparation containing an acid labile compound together with and alkaline reacting compound for the treatment of gastrointestinal diseases.
Bodó et al., U.S. Pat. No. 4,925,878, describe a composition especially suited for the treatment of the nausea and vomiting symptoms associated with motion sickness.
Numerous drugs have been developed for the treatment of chemotherapy-induced vomiting and nausea. Zofran®, a prescription antiemetic drug containing ondansetron as the active component, is a highly selective antagonist of serotonin receptors. Clinically accepted for use in treating cancer chemotherapy-induced nausea and vomiting, post-operative nausea and vomiting, and radiotherapy induced nausea and vomiting, this medication is not accepted for use in the treatment of motion-sickness or for prescription to pregnant or nursing women.
Drug Information for the Health Care Professional
, 2179 (17
th
Ed., 1997).
Kytril®, another prescription antiemetic, containing the active component granisetron, also works as a highly specific antagonist of serotonin receptors. Clinically, Kytril® is only accepted for use in treating cancer chemotherapy-induced nausea and vomiting and has not been proven safe for prescription to pregnant or nursing women. Id. at 1532.
In relation to the treatment of nausea and/or vomiting in pregnant women, different approaches have been attempted in order to avoid teratogenicity or at least reduce the risk of birth defects commonly associated with certain drugs for treating nausea and vomiting.
Studies have shown that certain vitamins may reduce nausea and/or vomiting. Administration of pyridoxine was shown to be effective in relieving the severity of nausea in early pregnancy without being teratogenic. Vutyavanich, et al., “Pyridoxine for nausea and vomiting in pregnancy:
a randomized, double-blind, placebo-controlled tri
Hermelin Marc S.
Kirschner Mitchell I.
Levinson R. Saul
Drugtech Corporation
Nath Gary M.
Nath & Associates PLLC
Spear James M.
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