J&J’s Invega Trinza Is First Three-Month Atypical Antipsychotic
This article was originally published in The Pink Sheet Daily
Executive Summary
The company plans to launch the three-month version of paliperidone palmitate in June following its approval by FDA.
As use of atypical antipsychotics moves increasingly towards long-acting injectables for the treatment of schizophrenia, Johnson & Johnson appears well positioned to continue to dominate the market with the launch of Invega Trinza, a three-month version of paliperidone palmitate, which is currently available as a once monthly injection.
J&J announced the FDA approval of Invega Trinza May 19, after a priority review. It will be the first schizophrenia medication that can be administered just four times a year, providing the longest dosing interval available to patients. J&J said it plans to launch Invega Trinza in June.
Before starting treatment with Invega Trinza, patients must be treated with Invega Sustenna, the once-monthly version, for at least four months, according to labeling.
J&J has dominated the long-acting injectable market since the introduction of Risperdal Consta (risperidone), which launched in the U.S. in 2003. The company followed up in 2009 with Invega Sustenna. The two products together generated sales of $2.78 billion in 2014, with sales of Risperdal Consta, dosed twice a month, slipping compared to a year ago and sales of Invega Sustenna up 27%.
More recently, however, new competition has begun to enter the market, including the first long-acting version of Otsuka Pharmaceutical Co. Ltd.’s Abilify (aripiprazole), which the Japanese pharma launched in the U.S. with partner Lundbeck Inc. in 2013 under the brand name Abilify Maintena. The short-acting tablet version of Abilify was the market leading brand in the highly genericized market, but it lost patent protection this year, and Teva Pharmaceutical Industries Ltd. launched the first generic version in April (Also see "Long-Acting Atypical Antipsychotic Market Snapshot: A One-Company Market Begins To Diversify" - Pink Sheet, 18 Mar, 2013.).
Alkermes PLC is ramping up to launch its own long-acting version of Abilify later this year (.The company developed the long-acting technology used in Risperdal Consta and both long-acting Invega products and receives royalties on sales. Alkermes’ once-monthly version of Abilify, aripiprazole lauroxil, is pending at FDA with a user fee date of Aug. 22.
The launch of Invega Trinza could give J&J a leg up in the changing market. The promise behind the long-acting injectable antipsychotics is that they can help schizophrenia patients, who are known to struggle with compliance, stick to their treatment regimen.
Given the well-understood adherence problem among patients with mental health disorders, payers too are more willing to reimburse for a branded long-acting injectable – even when short-acting generics are available – if it can help patients comply. Lack of patient compliance with taking medications accounts for 40% of re-hospitalizations in the therapeutic area and costs upwards of $13,000, according to data from J&J.
In a long-term maintenance trial, 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. The results of the Phase III trial, which tested Invega Trinza compared to placebo, were published in JAMA Psychiatry in March. The trial was halted early due to efficacy. The safety of Trinza was consistent with other marketed paliperidone formulations.
Invega Trinza is available in four doses (373 mg, 410 mg, 546 mg and 819 mg). The doses are 3.5-fold higher than the corresponding doses of Invega Sustenna, but result in exposures similar to those obtained with the corresponding once-monthly dose. Paliperidone is also sold as Invega, once-daily extended-release tablets. Invega tablets generated $640 million in sales in 2014.
Meanwhile, J&J announced May 11 that its attempt to add data from a “real-world” trial to labeling for Invega Sustenna received a “complete response” letter from FDA, though the company declined to say why (Also see "Keeping Track: For Invega Sustenna, PRIDE Comes Before The "Complete Response"" - Pink Sheet, 18 May, 2015.). The company had been looking to add data from the open-label PRIDE trial, which enrolled 444 adults with schizophrenia, who were recruited to be reflective of “real-world” clinical practice, incorporating patients from homeless shelters, soup kitchens and jail-release programs. The study showed treatment with Invega Sustenna delayed time to relapse for a median of 416 days versus 226 days for patients randomized to one of seven flexibly-dosed common oral antipsychotics.