FARMVILLE, N.C., June 21, 2023/ — CMP Pharma, Inc. announced today that Liqrev (Sildenafil) Oral Suspension, 10 mg/mL, the first and only FDA-approved ready-made oral liquid of sildenafil, is now available.
Liqrev is a liquid oral suspension of sildenafil formulated for patients with dysphagia or difficulty swallowing tablets. Liqrev is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening.
FDA-approved Liqrev addresses the inconsistencies that come from unapproved crushed or compounded tablets and removes the need for complex preparation of powder formulations. Liqrev has a strawberry flavor and is available in 122 mL bottles with a 24-month shelf life.
“Liqrev is for patients who need a liquid formulation because they have difficulty swallowing tablets. This product is a nice addition to our portfolio of liquids for patients with pulmonary arterial hypertension (PAH),” said Gerald Sakowski, CEO of CMP Pharma, Inc.
Liqrev 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.
About Liqrev
LIQREV is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.
LIQREV is contraindicated in patients with: concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension; concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat; known hypersensitivity to sildenafil or any component of the oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
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
Adults
LIQREV is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.
Contraindications
LIQREV is contraindicated in patients with:
Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension.
Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.
Known hypersensitivity to sildenafil or any component of the oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
Warnings and Precautions
- Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.
- Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended.
- Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs.
- Pulmonary hypertension (PH) secondary to sickle cell disease: LIQREV may cause serious vaso-occlusive crises.
Adverse Reactions
Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back pain, and diarrhea
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 – Concomitant use of LIQREV with nitrates in any form is contraindicated
- Strong CYP3A Inhibitors – Concomitant use of LIQREV with strong CYP3A inhibitors is not recommended.
- Moderate-to-Strong CYP3A Inducers – Concomitant use of LIQREV with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure.
- Concomitant PDE-5 inhibitors – Avoid use with VIAGRA or other PDE-5 inhibitors.
Dosage and Administration
Recommended Dosage in Adults – The recommended dosage of LIQREV is 20 mg orally three times a day. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. Shake well for at least 10 seconds before use.
Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.
Please see www.liqrev.com/prescribing-information for additional safety information.
Source: CMP Pharma, Inc.
Posted: June 2023
