CMP Pharma, Inc Announces that Tadliq®, the First and Only FDA-approved Liquid Suspension of Tadalafil, is Now Available

News provided by

CMP Pharma

Oct 24, 2022, 09:30 ET

FARMVILLE, N.C., Oct. 24, 2022 /PRNewswire/ -- CMP Pharma announced today that Tadliq® (Tadalafil) Oral Suspension, 20 mg/5 mL, the first and only FDA-approved oral liquid suspension of tadalafil, is now available.

Tadliq is the first and only FDA-approved liquid oral suspension of tadalafil for adult patients with difficulty swallowing. Tadliq is indicated for the treatment of pulmonary arterial hypertension and ensures consistent dosing.

FDA-approved Tadliq addresses the inconsistencies that come from unapproved crushed or compounded tablets and removes the need for complex preparation of powder formulations. Tadliq has a mild peppermint flavor and is available in 150 mL bottles with a 24-month shelf life.

"Tadliq is for patients who need treatment but have difficulty swallowing tablets. This product is a nice addition to our portfolio of cardiovascular liquids for this specific patient population which is often ignored", said Gerald Sakowski, CEO of CMP Pharma, Inc.

Tadliq is available through three preferred specialty pharmacies and selected wholesalers. CMP Pharma also supports physicians and patients through the CMP Support Services program. Support service representatives are available Monday through Friday from 8 AM to 5 PM EST by contacting the program at 1-844-267-0001.

Tadliq (Tadalafil) Oral Suspension is now available. For more information, contact CMP Pharma at 252-753-7111 or visit tadliq.com.
About Tadliq

Tadliq is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Tadliq is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently.

About CMP Pharma, Inc.

CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including oral liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.

Important Safety Information
Indications and Usage

TADLIQ® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Contraindications
  • Concomitant organic nitrates
  • Concomitant Guanylate Cyclase (GC) Stimulators
  • History of known serious hypersensitivity reaction to TADLIQ, ADCIRCA® or CIALIS®
Warnings and Precautions
  • Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of TADLIQ. Not recommended in patients with pulmonary veno-occlusive disease.
  • Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent.
  • Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with tadalafil.
  • Concomitant PDE5 inhibitors: Avoid use with CIALIS, ADCIRCA or other PDE5 inhibitors.
  • Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours.

To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions
  • Nitrates: Administration of nitrates within 48 hours after the last dose of TADLIQ is contraindicated
  • Alpha-Blockers: PDE5 inhibitors, including TADLIQ, and alpha-adrenergic blocking agents are both vasodilators with blood- pressure-lowering effects.
  • Antihypertensives: PDE5 inhibitors, including TADLIQ, are mild systemic vasodilators.
  • Alcohol: Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators.
  • CYP3A Inhibitors/Inducers: Ritonavir, Potent Inhibitors of CYP3A, Potent Inducers of CYP3A
Dosage and Administration

The recommended dose of TADLIQ is 40 mg (10 mL) taken once daily with or without food.

Please click link for full Prescribing Information: https://www.tadliq.com/prescribing-information/

TAD-00030

SOURCE CMP Pharma

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