In 2018, we also made significant improvements in patient access for BELBUCA, resulting in
over 100 million commercial lives having preferred access to BELBUCA. According to Symphony Health, in 2018, BELBUCA prescriptions totaled over 160,000, an increase of 91% over 2017. In addition to a steady increase in BELBUCA prescription
volume throughout 2018, there was also an increase in the use of higher doses of BELBUCA as healthcare providers continued to gain comfort titrating patients to higher optimal doses. In 2018, 36% of BELBUCA prescriptions were for doses of 450 mcg or
greater, compared to 33% in 2017. Therefore, the weighted average price per prescription continued to increase in 2018.
According to data
from Symphony Health, monthly prescriptions for BELBUCA totaled 20,681 and 20,664 for January 2019 and February 2019, respectively, and are projected to have been approximately 22,512 for March 2019. Further, according to IQVIA NPA Market Dynamics,
new-to-brand
prescriptions for BELBUCA totaled 4,263 and 4,588 for January 2019 and February 2019, respectively. Also according to Symphony Health, in January 2019 and
February 2019, there were 4,228 and 4,350 unique prescribers of BELBUCA and 424 and 375 new prescribers of BELBUCA, respectively. As of April 2019, more than 50% of commercial covered lives and more than 20% of Medicare covered lives,
respectively, had access to BELBUCA as a preferred medication.
SYMPROIC
On April 4, 2010, we entered into an exclusive license agreement, or the license agreement, with Shionogi Inc., or Shionogi, to
commercialize Symproic (
naldemedine tosylate
) 0.2 mg tablets in the United States, including Puerto Rico, effective immediately. See Recent Developments.
Symproic is a peripherally acting
mu-opioid
receptor antagonist, or PAMORA, and was approved by the
FDA on March 23, 2017 for the treatment of opioid-induced constipation, or OIC, in adult patients with chronic
non-cancer
pain, including patients with chronic pain related to prior cancer or its
treatment who do not require frequent (e.g., weekly) opioid dosage escalation. OIC occurs primarily via activation of enteric
mu-receptors
in the small intestine and proximal colon, which results in harder
stool and less frequent and less effective defecation. Because OIC results from the specific effects of opioids, it differs mechanistically from other forms of constipation, and deserves dedicated medical management. Compared to currently marketed
products and products under development for OIC, we believe that Symproic is differentiated based on the following features:
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strong and durable efficacy observed in randomized, double-blind, placebo controlled clinical trials of 12 week
and 52 week duration in OIC patients;
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OIC relief that was more frequent, more complete, with less straining than patients taking placebo
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recommended by the American Gastroenterological Association for patients with laxative refractory OIC;
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adverse event profile comparable to placebo, with low rates of abdominal pain observed across the phase III
program; and
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the only prescription OIC medication with the convenience of once daily dosing, with only a tablet strength, and
that can be taken with or without food and with or without laxatives.
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Because of the durable efficacy, tolerability and
convenience benefits, we believe that Symproic is a
best-in-class
PAMORA that reliably provides durable relief of OIC, which frees both the patient and the healthcare
provider to focus on treating the patients chronic pain.
We believe that there are long-term growth opportunities for Symproic. In
2018, according to data from Symphony Health, the market for PAMORAs included over 550,000 prescriptions dispensed. This represents a 1% growth in prescription volume from 2017. The growth rate of the PAMORAs has slowed since 2017, driven by a
decline in opioid prescription rates.
BUNAVAIL
In June 2014, BUNAVAIL
(buprenorphine and naloxone buccal film)
was approved by the FDA for the maintenance treatment of opioid
dependence as part of a complete treatment plan to include counseling and psychosocial support. In May 2017, we announced that the FDA had approved a Supplemental New Drug Application, or sNDA, for BUNAVAIL revising the BUNAVAIL indication to
include induction, or the