PHILADELPHIA, May 6 /PRNewswire/ -- URL Pharma, Inc., today announced that the U.S. Food and Drug Administration (FDA) has issued new label information affecting all approved protease inhibitors for treatment of HIV when co-administered with Colcrys® (colchicine, USP). These dosing guidelines are intended to avoid potentially fatal drug-drug interactions.
These new dosing recommendations were issued as a result of several clinical studies designed and conducted by URL Pharma that uncovered the risk of serious interactions when colchicine is taken along with certain other prescription medications. In addition to protease inhibitors, the URL Pharma studies discovered potentially dangerous interactions between colchicine and certain hypertension medications and antibiotics. URL Pharma conducted 17 clinical trials as part of its submissions to the FDA in the 3 New Drug Applications (NDAs) filed for Colcrys.
"The drug-drug interaction studies we conducted for Colcrys have yielded new and critically important guidance for physicians on the safe and appropriate use of colchicine, particularly among special populations, and represent a significant public health milestone in the treatment of gout," said Matthew W. Davis, M.D., R.Ph., Chief Medical Officer. "Prior to our work, scientifically rigorous guidance on dosing colchicine to avoid drug interactions was virtually non-existent. We urge all healthcare providers to consult the new labeling for protease inhibitors prior to concomitant use with Colcrys."
New Colcrys Dosing Guidance
The new dosing adjustment covers all approved protease inhibitors for the treatment of HIV-1 infection, including Lexiva® (fosamprenavir calcium) and ritonavir.
- Patients with hepatic or renal impairment: For the prevention or treatment of gout flares, or for FMF, FDA has recommended against the co-administration of Colcrys with protease inhibitors.
- Acute gout flares: The new recommended dosing for the treatment of gout flares is 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour later; this dose to be repeated no earlier than 3 days.
For patients taking Lexiva without ritonavir, the suggested dose is 1.2 mg (2 tablets) x 1 dose; this dose is to be repeated no earlier than 3 days.
- Prophylaxis of Gout Flares: In patients taking Colcrys for the prophylaxis of gout flares, FDA recommends that if the original colchicine regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg once a day. If the original colchicine regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once every other day.
In patients taking Lexiva without ritonavir, FDA recommends that if the original Colcrys regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg twice a day or 0.6 mg once a day. However, if the original Colcrys regimen was 0.6 mg once a day, FDA recommends it be adjusted to 0.3 mg once a day.
- Familial Mediterranean fever (FMF): In patients with FMF, FDA recommends a maximum daily dose of Colcrys of 0.6 mg (may be given as 0.3 mg twice a day) when co-administered with protease inhibitors.
However, in FMF patients taking Lexiva without ritonavir, the maximum daily dose of Colcrys is recommended to be no more than 1.2 mg (may be given as 0.6 mg twice a day).
Additional information about the new label information affecting all approved protease inhibitors for the treatment of HIV may be found at the FDA website: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm209920.htm.
"At URL Pharma, patient safety is our primary concern," said Richard H. Roberts, M.D., Ph.D., President, Chief Executive Officer and Chairman of URL Pharma. "This is evidenced by the fact that our rigorous clinical program for Colcrys discovered these previously unknown drug-drug interactions. Patients and physicians should feel confident that they are prescribing and using a thoroughly tested, FDA-approved medication that meets all modern standards of safety, efficacy, purity, consistency and labeling."
Colcrys received approval from the U.S. Food and Drug Administration (FDA) on July 30, 2009 for use in treating acute gout flares at the first sign of a flare, and for the treatment of FMF. Colcrys received FDA approval for the prophylaxis of gout flares on October 19, 2009. It is the first and only single-agent colchicine treatment to receive FDA approval.
About Gout and Painful Gout Flares
Gout is a painful form of arthritis that affects an estimated 3 to 5 million Americans, most commonly adult men. It occurs when excess uric acid in the body is deposited as needle-like crystals, or tophi, in the joints or soft tissues, which cause inflammatory arthritis and can lead to gout flares typically lasting three to 10 days.
Gout flares are characterized by intermittent swelling, redness, heat, joint stiffness and pain, which are often excruciating and can be debilitating enough to significantly interfere with work, social activities and daily living. For many people, gout initially affects the joint of the big toe, though it can also affect other joint areas such as the ankles, heels, knees, wrists, fingers and elbows.
Important Safety Information
COLCRYS (colchicine, USP) tablets are indicated for the treatment of acute gout flares.
COLCRYS is contraindicated in patients with renal or hepatic impairment who are concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as life-threatening or fatal toxicity has been reported. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors. The most common adverse events in clinical trials for the prophylaxis and treatment of gout were diarrhea and pharyngolaryngeal pain. Rarely, myelosuppression, thrombocytopenia, and leukopenia have been reported in patients taking colchicine. Rhabdomyolysis has been occasionally observed, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Monitoring is recommended for patients with a history of blood dyscrasias or rhabdomyolysis.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call1-800-FDA-1088.
You may also report negative side effects to the manufacturer of COLCRYS by calling 1.888.351.3786.
For full Prescribing Information, please visit: http://www.colcrys.com/assets/pdf/COLCRYS_Full_Prescribing_Information.pdf
About URL Pharma
URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically innovative products that address unmet medical needs for improvements in safety and efficacy. The Company's profits are derived predominantly from its exclusive products and technologies. For additional information about the company, please visit www.urlpharma.com. For further information, please call 215-697-1900 or firstname.lastname@example.org.
Lexiva® is a registered trademark of Vertex Pharmaceuticals, Inc.
SOURCE URL Pharma, Inc.