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Adlon Therapeutics L.P. and Purdue Pharma L.P. to Present Six Scientific Posters at the 2020 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting

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Data to include outcomes from a Phase 3 Adult Laboratory Classroom study to evaluate the safety and efficacy of Adhansia XR™ (methylphenidate hydrochloride) extended-release capsules CII compared to placebo for the treatment of ADHD

STAMFORD, Conn.–(BUSINESS WIRE)–Adlon Therapeutics L.P. and Purdue Pharma L.P. today announced that six posters highlighting PRC-063 data as well as research on real-world treatment patterns and patient preferences will be presented at the 2020 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting in Washington D.C. PRC-063 was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older and is currently available as Adhansia XR™ (methylphenidate hydrochloride) extended-release capsules CII.

The Full Prescribing Information for Adhansia XR contains a boxed warning for abuse and dependence. CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence. Healthcare professionals should assess the risk of abuse prior to prescribing Adhansia XR and monitor for signs of abuse and dependence while patients are on therapy.1

Among the data to be presented are results from a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 Adult Laboratory Classroom (ALC) study that was completed post-approval to evaluate the safety and efficacy of Adhansia XR for the treatment of ADHD in adults (Poster #3 at Poster Session 2, Saturday, January 18 at 12:30-2:30 PM). The efficacy assessment evaluated Adhansia XR compared to placebo using standardized, skill-adjusted math tests to measure a patient’s attention across the day. Post-washout, patients were dose-optimized on Adhansia XR (25-100 mg/day) over seven weeks before randomization to Adhansia XR or placebo for a one-week double-blind treatment period which ended with one full-day evaluation in an ALC. Average test scores during the full-day ALC visit were higher in patients treated with Adhansia XR (n=116) than in patients receiving placebo (n=113) [LS mean difference (95% CI): 16.3 (7.6, 24.9); p=.0003]. Compared to placebo, patients receiving Adhansia XR had higher post-dose test scores at every individual timepoint from one hour up to and including 16 hours (all p<.05).

During dose-optimization, the most frequently reported treatment emergent adverse events (TEAEs) were headache (21.4%), decreased appetite (21.4%), and insomnia (16.1%). During the double-blind period, the most frequently reported TEAEs in the Adhansia XR and placebo groups included headache (Adhansia XR: 4.1%; placebo: 2.5%), fatigue (Adhansia XR: 3.3%; placebo: 0.8%), and upper respiratory tract infection (Adhansia XR: 1.7%; placebo: 2.5%).

“As a research-driven organization, we continually strive to improve the understanding of our products across their lifecycle stages. While Adhansia XR is not appropriate for all patients with ADHD, we believe it has the potential to address the needs of certain patients who may require a longer treatment duration,” said Mike Ronning, vice president, sales and marketing, and general manager, Adlon Therapeutics. “Beyond our mission to develop and provide treatment options for ADHD and related disorders, Adlon Therapeutics continues to support initiatives designed to improve patient awareness of prescription stimulants as scheduled medications that must be responsibly used, stored, and disposed.”

Additional posters presented at APSARD include:

Adhansia XR Studies

General ADHD Studies

“We are committed to maintaining research partnerships that advance understanding of ADHD and related conditions, and the medicines that help to manage associated symptoms,” said Craig Landau, MD, president and CEO, Purdue Pharma. “It is important for our current and future business goals to continue making medications like Adhansia XR available for appropriate patients. Scientific programs like these provide a foundation for maintaining our value to the medical community as we emerge as a corporate entity dedicated to benefiting public health.”

Adhansia XR is not appropriate for all patients, and healthcare professionals should work with their patients to determine the most appropriate treatment option. Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or product components, as well as patients receiving concurrent treatment with a monoamine oxidase inhibitor (MAOI) or who have used an MAOI within the preceding 14 days.1

The Full Prescribing Information for Adhansia XR, including Boxed Warning, is available at this link. Please see Important Safety Information for Adhansia XR below, including the Boxed Warning, Contraindications, Warnings and Precautions including the potential for abuse and dependence, serious cardiovascular events, blood pressure and heart rate increases, psychiatric adverse reactions, priapism, peripheral vasculopathy, long-term suppression of growth, allergic-type reactions, and Adverse Reactions.1

About Adhansia XR™

Adhansia XR was developed by Purdue Pharma (Canada). The medication was granted marketing authorization from Health Canada in December 2017 and is currently marketed in Canada as FOQUEST™ for the treatment of ADHD. In the U.S., the medication was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older in February 2019.

Adhansia XR capsules contain multilayered beads, which are composed of an immediate-release layer which contains approximately 20 percent of the methylphenidate dose, and a controlled-release layer which contains approximately 80 percent of the methylphenidate dose, for oral administration. The MLR™ (multi-layer release) technology is a controlled-release delivery system patented by Purdue Pharma.

Please see Important Safety Information, including Boxed Warning, Warnings & Precautions, and Adverse Reactions below.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

CONTRAINDICATIONS

Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products. Adhansia XR is also contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis.

WARNINGS AND PRECAUTIONS

Potential for Abuse and Dependence

CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

Serious Cardiovascular Events

Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulant treatment at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Adhansia XR treatment.

Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Psychiatric Adverse Reactions

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Adhansia XR. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% in placebo-treated patients.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products, in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud’s Phenomenon

CNS stimulants, including Adhansia XR, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Adhansia XR. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Allergic-Type Reactions: FD&C Yellow No. 5

Adhansia XR 45 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

ADVERSE REACTIONS

The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in adults are insomnia, dry mouth, and decreased appetite.

The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in pediatric patients are decreased appetite, insomnia, and weight decreased.

PREGNANCY EXPOSURE REGISTRY

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adhansia XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please read Full Prescribing Information, including Boxed Warning.

About Adlon Therapeutics L.P.

Adlon Therapeutics L.P. is a biopharmaceutical company dedicated to developing and providing treatment options for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders. Our initial focus is on adults and adolescents who have been diagnosed with ADHD. Adlon is a subsidiary of Purdue Pharma L.P. For more information, please visit www.adlontherapeutics.com.

About Purdue Pharma L.P.

Purdue Pharma and its subsidiaries are physician-founded and physician-led companies that develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers. Purdue Pharma is also committed to supporting national, regional and local collaborations to drive innovations in patient care while continuing our efforts to address the opioid addiction crisis.

Purdue’s subsidiaries include: Adlon Therapeutics L.P., focused on treatment options for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders; Avrio Health L.P., a consumer wellness company that provides over-the-counter products to fight infection, promote digestive regularity and support muscle and brain function; Imbrium Therapeutics L.P., established to develop and commercialize non-opioid pain medications and therapies for select oncology and CNS disorders; Rhodes Pharmaceuticals L.P., which develops and supplies primarily solid oral-dose and transdermal medications; Rhodes Technologies, which develops and manufactures active pharmaceutical ingredients; and Greenfield Bioventures L.P., an investment vehicle focused on compounds in the early stages of clinical development.

For more information, visit www.purduepharma.com.

Reference:

  1. Purdue Pharma L.P. Adhansia XR Full Prescribing Information. May 2019. Accessed January 2020. Retrieved from http://app.adlontherapeutics.com/adhansia-xr/fpi.pdf.

 

Contacts

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