Cranbury Pharmaceuticals Receives U.S. FDA Approval for First Generic Version of Emflaza® Oral Suspension (deflazacort) for Duchenne Muscular Dystrophy

– Cranbury, a new subsidiary of Tris Pharma, will market more than 20 generic medicines and advance a diverse pipeline transitioned from Tris –

– Deflazacort oral suspension is indicated to treat patients five years of age and older for Duchenne muscular dystrophy, a rare disease with limited treatment options available –

– Immediate commercial availability of therapy underscores Cranbury’s commitment to providing patients with access to effective generic medicines across multiple disease states –

Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, today announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza^® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States.

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Deflazacort oral suspension is indicated to treat DMD in patients five years of age and older. DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness. The disease primarily affects boys, with symptom onset in early childhood. DMD occurs in approximately 1 in 5,000 live male births, and it is estimated that about 20,000 children are diagnosed with DMD globally each year.¹

“Tris Pharma founded Cranbury as part of the company’s continued commitment to develop high-quality medicines and make them accessible to individuals who need them,” said Janet Penner, president at Cranbury Pharmaceuticals. “The launch of deflazacort oral suspension aligns with this commitment, and we are proud to provide this critical therapy to those with DMD. As a tenured member of the Tris team, I am honored to take on the role of president of our new subsidiary and have the opportunity to provide important generic medicines to patients with a range of disorders and diseases.”

Tris founded Cranbury Pharmaceuticals with the vision to create high-quality, patient-friendly generic medicines that leverage Tris’ strengths in product selection, development and commercial launch. Cranbury will market more than 20 generic medicines and advance a diverse pipeline with the potential to address a range of disorders and diseases. The company will operate out of Tris’ headquarters in Monmouth Junction, New Jersey.

“Duchenne muscular dystrophy is a devastating rare disease, and with limited treatment options available there is a critical need for the greater accessibility that a generic therapy can bring,” said Ketan Mehta, founder and CEO at Tris Pharma. “This FDA approval is a significant milestone for the patients, caregivers and physicians who may depend on this medication to treat DMD. Our portfolio of differentiated, high-quality generic medications has always been core to our business at Tris, and I look forward to continuing to expand our generic offerings under our new subsidiary, Cranbury Pharmaceuticals.”

The spinout of Cranbury Pharmaceuticals follows Tris Pharma's recent launch of Tris Digital Health, a business focused on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions. The creation of these subsidiaries within Tris facilitates important progress and enables significant continued growth for the company’s digital health and generics portfolios. Tris Pharma will continue to focus on building its commercial portfolio of approved, best-in-class ADHD products and advancing its late-stage pipeline of innovative therapeutics in pain, ADHD, neurological disorders and addiction.

INDICATION

DEFLAZACORT oral suspension is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications:

• DEFLAZACORT is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients in deflazacort oral suspension.

Warnings & Precautions

• Alterations in Endocrine Function: Corticosteroids, such as DEFLAZACORT, oral suspension, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving DEFLAZACORT oral suspension for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after deflazacort oral suspension withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency, or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events. Acute adrenal insufficiency or “withdrawal syndrome” can occur if corticosteroids are withdrawn abruptly and can be fatal. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. During times of medical stress, corticosteroid dosage may need to be increased.
• Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; Signs and symptoms of infection may be masked. Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on corticosteroids who have not had chickenpox or measles to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed.
• Alterations in Cardiovascular/Renal Function: Corticosteroids, including DEFLAZACORT oral suspension, can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium and calcium. DEFLAZACORT oral suspension should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Monitor for elevated blood pressure. Dietary salt restriction and potassium supplementation may be needed.
• Gastrointestinal Perforation: Increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, and non-specific ulcerative colitis. Signs and symptoms may be masked. Avoid corticosteroids if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.
• Behavioral and Mood Disturbances: Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including DEFLAZACORT oral suspension. Psychiatric adverse reactions usually involve hypomanic or manic symptoms (e.g., euphoria, insomnia, mood swings) during treatment and depressive episodes after discontinuation of treatment. Encourage patients to seek medical attention if symptoms develop or worsen. especially if depressed mood or suicidal ideation is suspected.
  
  Effects on Bones: Corticosteroids, including DEFLAZACORT oral suspension, decrease bone formation and increase bone resorption. The risk of osteoporosis increases with prolonged use of DEFLAZACORT, which can predispose patients to vertebral and long bone fractures. Consider a patient’s risk of osteoporosis before initiating corticosteroid therapy. Monitor bone mineral density in patients on long-term treatment with DEFLAZACORT, oral suspension.
• Ophthalmic Effects: May cause cataracts, infections, and glaucoma; Monitor intraocular pressure if DEFLAZACORT oral suspension is continued for more than 6 weeks.
• Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Administer live attenuated or live vaccines at least 4 to 6 weeks prior to starting DEFLAZACORT oral suspension.
• Serious Skin Rashes: Toxic epidermal necrolysis has been reported with the use of deflazacort with symptoms beginning within 8 weeks of starting treatment. Discontinue at the first sign of rash, unless the rash is clearly not drug related.
• Effects on Growth and Development: Long-term use of corticosteroids, including DEFLAZACORT oral suspension, can have negative effects on growth and development in children.
• Thromboembolic Events: Observational studies have shown an increased risk of thromboembolism. Use DEFLAZACORT oral suspension with caution in patients who have or may be predisposed to thromboembolic disorders.
• Adverse Reactions: The most common adverse reactions (≥10% for DEFLAZACORT Oral suspension and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis.
• Drug Interactions: Give one third of the recommended dosage of DEFLAZACORT oral suspension. Avoid use of moderate or strong CYP3A4 inducers with deflazacort oral suspension, as they may reduce efficacy.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see Full Prescribing Information here.

About Cranbury Pharmaceuticals

Cranbury Pharmaceuticals is a subsidiary of Tris Pharma focused on the development and commercialization of high-quality, patient-friendly products that leverage the company’s strengths in product selection, development and commercial launch. Driven by patient-focused innovation, Cranbury will market more than 20 generic products and advance a diverse pipeline ready to transform new ideas into approved, effective medicines. Learn more at www.cranburypharma.com.

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is leveraging its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

References

¹ Muscular Dystrophy Association. What is… Duchenne Muscular Dystrophy [Fact sheet]. https://www.mda.org/sites/default/files/2020/10/MDA_DMD_Fact_Sheet_Oct_2020.pdf.

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