King Pharmaceuticals, Inc. announced the US Food and Drug Administration (FDA) approval of the company's THROMBIN-JMI Epistaxis Kit, a new intranasal spray delivery device for THROMBIN-JMI (thrombin, topical, bovine, USP) for use to aid in stopping epistaxes (nosebleeds).
J. DavidOwens, senior vice president of King's Hospital & Surgical Products Division, commented, "We are excited about the addition of the THROMBIN-JMI Epistaxis Kit to our portfolio of THROMBIN-JMI based products. The kit offers healthcare professionals in the emergency department (ED) and trauma centre a convenient new option to achieve fast, active haemostasis during epistaxes." Owens emphasized, "This milestone demonstrates King's ongoing commitment to THROMBIN-JMI and further broadens its range of delivery options. We plan to begin marketing the THROMBIN-JMI Epistaxis Kit in the US by the fourth quarter of this year."
About three in five Americans experience nosebleeds during their lifetime. Certain high-risk groups, such as the elderly, require rapid intervention to stem bleeding, in order to prevent further complications and potentially life-threatening events. Active haemostats, such as THROMBIN-JMI®, the only bovine-derived thrombin currently available as a single agent, are biologically active agents that work directly at the end of the coagulation cascade (the process by which the multiple coagulation factors in the blood interact to form a clot). These products are effective at aiding in haemostasis of oozing blood and minor bleeding from accessible capillaries and small venules.
With the approval of the THROMBIN-JMI Epistaxis Kit, King will now offer two products for ED and trauma centre use. Launched earlier this year, THROMBI-Pad (3x3 haemostatic pad), the only composite of lyophilized (freeze-dried) THROMBIN-JMI and gauze pad, offers healthcare professionals in the ED and trauma centre a new option to achieve active haemostasis at bleeding sites where they would typically use trauma dressings.
"In the ED and trauma centre, healthcare professionals often do not have access to active haemostats to control nosebleeds, relying instead on plugging of the nostrils with gauze and other packing agents. However, these methods are often uncomfortable for patients and may impose certain health risks," said Abhi Mehrotra, MD, Assistant Medical Director, Department of Emergency Medicine University of North Carolina, Chapel Hill, NC. "The approval of the THROMBIN-JMI Epistaxis Kit will provide an alternative to current methods for treating nosebleeds in a convenient, easy-to-use device, and may enhance my ability to rapidly control active bleeding."
THROMBIN-JMI is indicated as an aid to haemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. Because of its clotting mechanisms, it should not be allowed to enter large blood vessels. In various types of surgery, solutions of THROMBIN-JMI® may be used in conjunction with an Absorbable Gelatin Sponge, USP for haemostasis.
In a small percentage of patients, the use of topical bovine thrombin preparations has been associated with abnormalities in haemostasis which rarely have been fatal and appear to be related to the formation of inhibitory antibodies. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.