Aucta Pharmaceuticals, Inc. (“Aucta Pharmaceuticals”) prepares for the launch of PYQUVI™ (deflazacort) oral suspension, the first of a new branded-generic rare disease product line

BASKING RIDGE, N.J., Feb. 6, 2026 /PRNewswire/ — Aucta Pharmaceuticals is pleased to announce the late January launch of PYQUVI oral suspension 22.75 mg/mL.  PYQUVI, a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older, is bioequivalent to Emflaza® (deflazacort) oral suspension 22.75 mg/mL.

PYQUVI will be available exclusively through a specialty pharmacy, offering an option for patients with DMD who prefer to receive deflazacort via a specialty pharmacy channel.

“Patients living with Duchenne muscular dystrophy and their families often face complex treatment-access considerations, including navigating evolving standards of care and insurance coverage variability that can delay timely therapy. These challenges add to the daily burden of a progressive condition such as Duchenne muscular dystrophy and underscore the importance of clear pathways to appropriate treatment and support,” said Dr. Marie Tan, Associate Director of Medical Affairs, Clinical Operations, and Pharmacovigilance at Aucta Pharmaceuticals, Inc. “As part of the PYQUVI launch, Aucta plans to offer a patient support program focused on access and specialty pharmacy coordination for eligible patients.”

The launch of PYQUVI marks Aucta Pharmaceuticals’ first commercial branded-generic product in the United States. Building on this milestone, Aucta Pharmaceuticals will be introducing ZELVYSIA^TM (sapropterin dihydrochloride) Powder for Oral Solution. ZELVYSIA is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). ZELVYSIA is to be used in conjunction with a Phe-restricted diet.

ZELVYSIA is anticipated to launch in March 2026, shortly following the introduction of PYQUVI.

Together, these launches represent a significant step forward in Aucta Pharmaceuticals’ branded generic portfolio. It also underscores our commitment to providing treatment options for patients and families affected by rare conditions.

Emflaza® is a registered trademark of PTC Therapeutics, Inc.

INDICATION

PYQUVI^TM is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

IMPORTANT SAFETY INFORMATION

PYQUVI is contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

• Alterations in Endocrine Function: Corticosteroids can cause serious and life-threatening endocrine alterations, especially with chronic use. Monitor for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after withdrawal. Risk is higher in patients with hypopituitarism, primary adrenal insufficiency, congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma. Acute adrenal insufficiency or “withdrawal syndrome” may occur if discontinued abruptly and can be fatal; taper gradually. Dose may need to be increased during times of medical stress.
• Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe or fatal. Signs of infection may be masked. Advise patients/caregivers to report recent infections or vaccinations. Patients without prior chickenpox or measles should avoid exposure and contact their healthcare provider immediately if exposed.
• Alterations in Cardiovascular/Renal Function: Monitor blood pressure; dietary salt restriction and potassium supplementation may be needed.
• Gastrointestinal (GI) Perforation: Risk is increased in patients with certain GI disorders (e.g., active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, inflammatory bowel disease). Signs may be masked.
• Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, depression, and psychosis. Advise patients to seek medical attention if symptoms develop or worsen.
• Effects on Bones: Prolonged use increases risk of osteoporosis, and vertebral and long bone fractures. Monitor bone density with chronic use.
• Ophthalmic Effects: May cause cataracts, ocular infections, or glaucoma. If corticosteroids are used for >6 weeks, monitor intraocular pressure.
• Vaccination: Do not administer live or live-attenuated vaccines during immunosuppressive corticosteroid therapy. Administer such vaccines at least 4 to 6 weeks before starting PYQUVI.
• Serious Skin Rashes: Toxic epidermal necrolysis has been reported. 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 may slow growth and development in children.
• Thromboembolic Events: Observational studies have shown an increased risk. Use with caution in at-risk patients.

ADVERSE REACTIONS

The most common adverse reactions (≥10% and greater than placebo) are Cushingoid appearance, weight gain, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis.

DRUG INTERACTIONS

• Moderate or strong CYP3A4 inhibitors: Use one third of the recommended PYQUVI dose.
• Moderate or strong CYP3A4 inducers: Avoid concomitant use as efficacy may be reduced.

To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Instructions for Use.

INDICATION

ZELVYSIA^TM (sapropterin dihydrochloride) is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients 1 month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). ZELVYSIA is to be used in conjunction with a Phe-restricted diet.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

• Hypersensitivity Reactions, Including Anaphylaxis: Avoid use in patients with a history of anaphylaxis to sapropterin. Discontinue treatment if anaphylaxis occurs and initiate appropriate medical care. Continue dietary Phe restrictions.
• Upper Gastrointestinal (GI) Mucosal Inflammation: Serious GI adverse reactions (eg, esophagitis, gastritis, ulcer, bleeding) have been reported. Monitor for signs and symptoms.
• Hypophenylalaninemia: May occur; increased risk in children <7 years of age treated with doses of 20 mg/kg per day. Monitor closely.
• Blood Phe Monitoring: Frequent blood Phe monitoring is required to ensure levels remain in the desirable range. Prolonged high Phe can cause severe neurologic damage (eg, intellectual disability, developmental delay, microcephaly, delayed speech, seizures, behavioral abnormalities). Prolonged low Phe can lead to catabolism and adverse developmental outcomes. Active management of dietary protein and Phe restriction is required.
• Lack of Biochemical Response: Not all patients with PKU respond. Assess response through a therapeutic trial; response cannot be pre-determined by laboratory testing.
• Interactions with Levodopa: May cause seizures, exacerbation of seizures, overstimulation, or irritability. Monitor for changes in neurologic status.
• Hyperactivity: Monitor for signs of hyperactivity.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥4%) are headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.

DRUG INTERACTIONS

• Folate Synthesis Inhibitors (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim): May decrease BH4 and increase Phe. Monitor Phe more frequently; adjust dosage as needed.
• PDE-5 Inhibitors (e.g., sildenafil, vardenafil, tadalafil): Both ZELVYSIA and PDE-5 inhibitors may induce vasorelaxation and hypotension. Monitor blood pressure.

To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Patient Information, and Instructions for Use.

About Aucta Pharmaceuticals, Inc.

Aucta Pharmaceuticals, Inc. is a research and technology-based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products. The company’s corporate strategy is to focus on proven molecules and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Its specialty division has a therapeutic focus in neurology/epilepsy, nasal delivery, and other specialty fields. For more information, visit www.auctapharma.com.

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SOURCE Aucta Pharmaceuticals, Inc.