Navigation Links
FDA Approves New Drug to Treat Type I and Type II Diabetes

The Food and Drug Administration (FDA) today approved Symlin, an injectable medicine to control blood sugar for adults with type 1 and type 2 diabetes. Symlin is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugars on intensive insulin therapy alone.

Symlin will be the only therapy for the treatment of type 1 diabetes other than insulin. Patients with type 2 diabetes already have several other types of oral therapies available.

The safety and efficacy of Symlin were studied in approximately 5000 patients. Overall Symlin therapy was associated, in patients with both types of diabetes, with improvements in the control of blood glucose and with weight loss. So-called "tight" control of blood sugar is desirable in all patients with diabetes in order to reduce risks for long-term adverse consequences of the disease, including blindness, kidney disease, and vascular disease.

Symlin is to be used only in combination with insulin to help lower blood sugar during the 3 hours after meals. Symlin will have a Medication Guide (FDA-approved patient labeling) and a Risk Minimization Action Plan (RiskMAP) due to three areas of concern. First, the principle risk associated with Symlin therapy is hypoglycemia, and this risk is greatest in patients with type 1 diabetes and in patients with gastroparesis (motility problems of the stomach-a long-term complication of diabetes). Second, the potential for medication errors, specifically mixing of Symlin with insulin in the same syringe, which can alter the activity of the insulin, is addressed in the Medication Guide and in physician labeling. Finally, the potential for off-label use in patients where the benefit/risk profile has not been characterized or demonstrated is also a concern and will be monitored by the sponsor.

The Medication Guide informs patients that Symlin should only be used if they are already using their insulin as prescribed, but still need better blood sugar control; will follow their doctor's instructions exactly; will follow-up with their doctor often; will test their blood sugar levels before and after every meal, and at bedtime; and understand how to adjust Symlin and insulin doses.

Symlin should not be used if patients cannot tell when their blood sugar is low, have gastroparesis (slow stomach emptying), or are allergic to pramlintide acetate, metacresol, D-mannitol, acetic acid, or sodium acetate.

Side effects associated with Symlin include but are not limited to nausea, vomiting, abdominal pain, headache, fatigue and dizziness.

Symlin has not been evaluated in the pediatric population.

Symlin is manufactured by Amylin Pharmaceuticals, Inc. of San Diego, California.


Source:US FDA

Related biology news :

1. FDA Approves Human Hookworm Vaccine for Phase I Safety Trials
2. FDA Approves New Treatment for Chronic Hepatitis B
3. Discovery Could Lead To Novel Approaches In HIV Treatment
4. New Treatment Rivals Chemotherapy For Lymphoma, Study Finds
5. Rush Physicians Using Gene Therapy For Heart Patients With Moderate To Severe Chest Pains Who Do Not Benefit From Other Treatments
6. Ophthalmologists Use Artificial Silicon Retina Microchip To Treat Vision Loss
7. Effective Cancer Treatments Follow The Clock
8. FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain
9. Potential Drug Target For Treating Cocaine Abuse Found
10. Protein Discovery Could Unlock The Secret To Better TB Treatment
11. Embryonic Stem Cells Treated With Growth Factor Reverse Hemophilia In Mice: UNC Researchers
Post Your Comments:

(Date:11/9/2015)... SAN JOSE, Calif. , Nov. 9, 2015 /PRNewswire/ ... of human interface solutions, today announced broader entry into ... of vehicle-specific solutions that match the pace of consumer ... drivers, and biometric sensors are ideal for the automotive ... the vehicle. Europe , ...
(Date:10/29/2015)... Oct. 29, 2015   MedNet Solutions , an ... spectrum of clinical research, is pleased to announce that ... Association (MHTA) as one of only three finalists for ... – Small and Growing" category. The Tekne Awards honor ... shown superior technology innovation and leadership. ...
(Date:10/29/2015)... ARBOR, Mich. , Oct. 29, 2015 /PRNewswire/ ... Eurofins Genomics for U.S. distribution of its DNA ... DNA-seq kit and Rubicon,s new ThruPLEX Plasma-seq kit. ... to enable the preparation of NGS libraries for ... plasma for diagnostic and prognostic applications in cancer ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... Nov. 24, 2015  Clintrax Global, Inc., a worldwide provider of ... , today announced that the company has set a new quarterly ... quarter on quarter growth posted for Q3 of 2014 to Q3 ... Mexico , with the establishment of an ... --> United Kingdom and ...
(Date:11/24/2015)... ... , ... This fall, global software solutions leader SAP and AdVenture Capital brought ... pitch their BIG ideas to improve health and wellness in their schools. , Now, ... the title of SAP's Teen Innovator, an all-expenses paid trip to Super Bowl 50, ...
(Date:11/24/2015)... LEXINGTON, Massachusetts , November 24, 2015 ... Officer, will participate in the Piper Jaffray 27 th Annual ... on Tuesday, December 1, 2015, at 8:30 a.m. EST (1:30 p.m. ... Poulton , Chief Financial Officer, will participate in the Piper Jaffray ... City , NY on Tuesday, December 1, 2015, at 8:30 ...
(Date:11/24/2015)... 24, 2015  Tikcro Technologies Ltd. (OTCQB: TIKRF) today announced that its ... at 11:00 a.m. Israel time, at the law ... Allon Street, 36 th Floor, Tel Aviv, Israel ... and Izhak Tamir to the Board of Directors; ... directors; , approval of an amendment to certain terms of options ...
Breaking Biology Technology: