Adcirca (tadalafil)

Approval Date
May 26, 2009

Release Date
May 26, 2009

United Therapeutics Corporation

Phosphodiesterase type 5 (PDE5) inhibitor

ADCIRCA(TM) (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). United Therapeutics licensed the rights to develop, market, promote and commercialize ADCIRCA for pulmonary hypertension in the United States and Puerto Rico from Eli Lilly & Company in November 2008. ADCIRCA contains the same active ingredient as CIALIS (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction (impotence) in more than 100 countries.

Active Ingredient

Agency Roster
MedThink Communications

Ignite Health

Marketing Strategy/Execution
United Therapeutics will promote to healthcare professionals who treat pulmonary arterial hypertension (PAH). It will be positioned as a first line oral agency for the treatment of PAH.

Physician Outlook
Adcirca’s (tadalafil) once-daily dosing sets it apart from other
phosphodiesterase type 5 (PDE5) inhibitors used to treat pulmonary arterial hypertension.  In addition to its convenience, Adcirca’s pricing is expected to be favorable, presenting a challenge to Pfizer’s Revatio (sildenafil citrate).

–Mary McBride, Associate Vice President, GfK Healthcare

Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: ACT-064992

Manufacturer: Actelion Pharmaceuticals

Indication: Pulmonary hypertension

Active ingredient: Macitentan

Phase: III

Drug: IPI 1040
Manufacturer: Encysive Pharmaceuticals / Praxis Pharmaceuticals

Indication: Pulmonary hypertension

Active ingredient: Sitaxentan

Phase: Launched

Drug: 15AU
Manufacturer: Aradigm Corporation/ Accredo Health

Indication: Pulmonary hypertension

Active ingredient: Treprostinil

Phase: Launched

Source: Wolters Kluwer Health

Adverse Reactions
Headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, pain, nausea, dyspepsia, sinus congestion; hypotension, vision or hearing loss, priapism.

40mg once daily. CrCl 31–80mL/min: initially 20mg once daily, increase to 40mg once daily if tolerated. CrCl<30mL/min: not recommended. Mild or moderate hepatic cirrhosis (Child Pugh Class A or B): initially 20mg once daily. Severe hepatic cirrhosis (Child Pugh Class C): not recommended. Concomitant ritonavir (for at least 1 week): initially 20mg once daily, may increase to 40mg once daily if tolerated. Stop tadalafil at least 24 hours prior to initiating ritonavir.

Not recommended.

Concomitant organic nitrates.

Cardiovascular disease (eg, clinically significant aortic and mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, left ventricular dysfunction, life-threatening arrhythmias, symptomatic coronary artery disease, hypotension (<90/50mmHg), uncontrolled hypertension). Pulmonary veno-occlusive disease: not recommended. Monitor for pulmonary edema. Anatomical penile deformation. Predisposition to priapism. Retinitis pigmentosa. Active peptic ulcer. Bleeding disorders. Pregnancy (Cat.B). Nursing mothers.

Hypotension with nitrates; allow at least 48 hours to elapse after last tadalafil dose before taking nitrates; administer nitrates under close supervision if taken within 48 hours of tadalafil for anginal chest pain. Concomitant potent CYP3A inhibitors (eg, ketoconazole, itraconazole) and potent CYP3A inducers (eg, rifampin): not recommended. Concomitant α-blockers (eg, doxazosin, alfuzosin, tamsulosin), alcohol may cause symptomatic hypotension. Concomitant other tadalafil products (eg, Cialis) or PDE5 inhibitors: not recommended. Caution with ritonavir (see Dose).