Why was xiaflex discontinued?

The decision to withdraw is not based on safety or efficacy concerns. Despite best efforts to appropriately educate the government and the market on XIAFLEX® over the past several years, the product did not receive government reimbursement approval and demand for the product has remained unsustainably low.

What is the success rate of XIAFLEX?

Studies have shown 34% improvement in penile curvature in men who underwent treatment with Xiaflex injection compared to 18% improvement in men treated with saline injection.

How safe is XIAFLEX?

XIAFLEX can cause serious side effects, including: Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection.

Why is XIAFLEX no longer available in Australia?

UPDATE JUNE 2019: The manufacturer has stopped selling Xiaflex in Australia. As far as I am aware, this is for business reasons rather than clinical or safety issues.

Is XIAFLEX available?

XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program. Hypersensitivity reactions, including anaphylaxis.

Optimizing Outcomes with Xiaflex Injections

Why was xiapex withdrawn?

The withdrawal was at the request of the marketing authorisation holder, Swedish Orphan Biovitrum AB (publ), which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Is XIAFLEX discontinued?

PRODUCT DISCONTINUATION FROM 28 JUNE 2019

It has provided a non-surgical option for patients with Dupuytren's Contracture and Peyronie's Disease.

How much do XIAFLEX injections cost?

Doctors who administer the drug will have to be specially trained and certified. Pain, swelling and bruising can develop in the injection area. Xiaflex costs $3,300 an injection, so a full course of eight injections would cost about $26,000, in addition to a doctor's fee.

What is XIAFLEX made from?

Xiaflex (collagenase clostridium histolyticum) is a biologic drug made from a mixture of proteins derived from Clostridium histolyticum bacteria. It works by breaking down excessive buildup of collagen, a structural protein in connective tissue.

Is XIAFLEX approved in Canada?

Xiaflex® is the first, non-surgical treatment approved by Health Canada for Dupuytren's Contracture. It presents itself as a less invasive treatment option for adult patients with this disease.

How many times can you have XIAFLEX?

No more than 3 injections, each 4 weeks apart, should be given in the same area. If you are using this medication to treat Peyronie's disease, the medication is injected into the plaque in the penis by your healthcare provider.

Is there a pill to cure Peyronie's disease?

The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie's disease.

Does XIAFLEX increase size?

Xiaflex with first generation PTT devices also had not impact on length. When patients used RestoreX along with the injection treatment, they experienced a nearly 2cm gain in length or about 17%.

What vitamins help with Peyronie's disease?

More recently, a 2014 study reported treatment outcomes of patients with PD using 50 mg sildenafil daily or 400 IU vitamin E for 3 months. After 12 weeks, both groups showed similar reduction in plaque volume and penile curvature that was statistically significant.

Can Peyronie's disease go away by itself?

Peyronie's disease rarely goes away on its own. In most men with Peyronie's disease, the condition will remain as is or worsen. Early treatment soon after developing the condition may keep it from getting worse or even improve symptoms.

How painful are XIAFLEX injections?

Pain. Although Xiaflex is not uncomfortable to receive, some patients have significant pain for up to 48 hours after the injection, with rare patients having discomfort beyond this period. Verapamil is more painful to receive, likely due to the volume of fluid, but is not significantly painful thereafter.

How long has XIAFLEX been on the market?

Xiaflex, originally approved in 2010 to treat the hand deformity Dupuytren's contracture, is the first available nonsurgical treatment option for Peyronie's disease, a condition in which scar tissue develops under the skin of the penis to form a lump.

Who invented XIAFLEX?

Ed Wegman, the company's founder, did not live to see the F.D.A. approval, dying at age 87 in 2007.

Who owns XIAFLEX?

XIAFLEX is a biologic owned by an affiliate of Endo International plc and it is sold in more than 20 countries around the world. Asahi Kasei Pharma received rights to develop and market XIAFLEX in Japan through an agreement concluded in March 2011.

Does insurance cover peyronies?

Medicare and most insurance plans cover the procedure in most cases. Billing specialists in the physician's office can help confirm your coverage.

What is the success rate for Peyronie's disease surgery?

They found the overall success rate of surgery was 96%, compared with 66% with CCH and 48% with traction. At a decade post treatment, traction was the most cost-effective with an average per-patient cost of $883, compared to $11,419 for surgery and $33,628 for CCH.

What is the latest treatment for Dupuytren's contracture?

Xiaflex was released last year by the FDA for non-surgically treating Dupuytren's contracture. This new injection, based in an enzyme, breaks down the diseased tissue allowing the finger to be easily manipulated into a straighter position. The first day the medicine is injected into the diseased 'cord' of tissue.

How long does it take to recover from XIAFLEX?

“It took me several weeks to recover from the incisions followed by thirty physical therapy sessions after each surgery. With Xiaflex, the recuperative process took only two weeks, and I was back to normal.”

Does XIAFLEX work for Dupuytren's contracture?

XIAFLEX^® is an FDA-approved, nonsurgical treatment for adults with Dupuytren's contracture when a cord can be felt. Studies show that prescription XIAFLEX^®, along with a finger extension procedure, may help straighten or nearly straighten the affected finger and improve range of motion after up to 3 injections.

Is XIAFLEX available in Europe?

Xiaflex treatment for Peyronie's disease available now in Europe.