MALVERN, Pa.
,
Oct. 25, 2024
/PRNewswire/ -- Endo, Inc. announced today that a post hoc data analysis of a Phase 3 clinical trial of XIAFLEX
®
(collagenase clostridium histolyticum, or CCH) in patients with Peyronie’s disease will be shared during SurgeWest, the 100
th
annual meeting of the Western Section of the American Urological Association (AUA), taking place
October 27-November 1, 2024
.
“I’m pleased to share this medical knowledge to help healthcare providers think of Peyronie’s disease phases in a different way than the current literature suggests, which may be serving to limit or postpone treatment options for patients suffering from the condition,” said Dr.
Jesse Mills
, urologist and presenting author of the study. “The outcomes for patients both with and without pain suggest that CCH may be an alternative to watchful waiting, regardless of the phase of disease.”
The Endo-supported research presentation is below:
Peyronie’s Disease Patients With Penile Pain at Baseline May Benefit From Collagenase Clostridium Histolyticum Treatment: A Post Hoc Analysis
Authors:
Jesse N. Mills
, MD;
Gregory A. Broderick
, MD;
Gregory J. Kaufman
, MD;
James P. Tursi
, MD;
Marian Ayad
, PharmD, BCPS;
Tina Rezakhani
, PharmD, MBA;
Sajel Patel
, PharmD;
Jeffrey Andrews
, MS;
Landon Trost
, MD
About the Post Hoc Phase 3 Data Analysis
1
A post hoc analysis of pooled data from two randomized, double-blind, placebo-controlled Phase 3 trials was conducted to evaluate CCH treatment and improvement in penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or >18 months.
CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or >18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline.
Data support that there were no clear differences in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus >18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy.
About Peyronie’s Disease
Peyronie’s disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be painful during arousal and intimacy.
2
It is estimated that PD can affect as many as 1 in 10 men in the U.S.,
3
but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.
4
About XIAFLEX
®
INDICATION
XIAFLEX
®
is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
IMPORTANT SAFETY INFORMATION FOR XIAFLEX
WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE
Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients.
Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.
Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie’s disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program.
Contraindications:
XIAFLEX is contraindicated in the treatment of Peyronie’s plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method
Corporal Rupture or Other Serious Injury to the Penis:
Injection of XIAFLEX into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie’s plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing
Hypersensitivity Reactions, Including Anaphylaxis:
In the double-blind, placebo-controlled portions of the clinical trials in Peyronie’s disease, a greater proportion of XIAFLEX-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX- associated pruritus was similar after each injection regardless of the number of injections administered
Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren’s contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known
Risk of Bleeding in Patients with Abnormal Coagulation:
In the XIAFLEX controlled trials in Peyronie’s disease, 65.5% of XIAFLEX-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
Acute Post-Injection Back Pain Reactions:
Post approval reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie’s disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient’s curvature deformity
Adverse Reactions
Clinical trials
In the XIAFLEX clinical trials for Peyronie’s disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain.
Post-marketing experience
Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments
Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention
Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie’s disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported
Click for
full Prescribing Information
, including Boxed Warning and
Medication Guide
.
About Endo
Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at
or connect with us on
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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Dr. Mills and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intends,” “guidance,” “future,” “potential” or similar expressions are forward-looking statements. Because these statements reflect Endo’s current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable safety or efficacy data; uncertainties in the regulatory approval process; compliance with regulatory obligations including those under the XIAFLEX REMS Program; unexpected litigation or other disputes; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the ability to develop and expand our product pipeline and to continue to develop the market for XIAFLEX® and other branded or unbranded products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of any strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo’s press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Endo’s most recent Form 10-Q and In Endo’s final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo’s Form S-1/A.
References:
Gelbard M, Goldstein I, Hellstrom W, et al.
J Urol.
2013;190(1):199-207.
Hellstrome WJ.
Int J Impot Res
. 2003;15:S91-S92.
Stuntz M, Perlaky A, des Vignes F, et al.
PLoS One
. 2016;11(2):e0150157.
DiBenedetti DB, Nguyen D, Zografoset L, al. Adv Urol. 2011:282503
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