Endo Health Solutions Inc.
ENDP announced today that its subsidiary, Endo Pharmaceuticals Inc.,
has launched 7.5mg and 15mg strengths of its reformulated, designed to be
crush-resistant, OPANA^® ER (oxymorphone HCl) product. Now commercially
available, the 7.5mg and 15mg options complete the launch of all approved
strengths of the reformulated version of OPANA ER with INTAC^® technology.
The product is now available in seven dosage strengths: 5, 7.5, 10, 15, 20, 30
and 40mg.
"Considering that a substantial amount of abuse and misuse of opioid products
is performed by manipulating the tablet through crushing and powdering, we are
excited to offer patients and healthcare professionals a full line of strength
options of the reformulated, designed to be crush-resistant, OPANA^® ER,"
stated Julie McHugh, chief operating officer, Endo Health Solutions. "Now
healthcare professionals and patients have seven strength options for extended
release oxymorphone (HCl) in a version designed to be crush-resistant. We see
this line completion as an important step forward for responsible pain
management."
With the launch of 7.5mg and 15mg OPANA ER designed to be crush-resistant,
Endo filed a false advertising suit against Actavis calling for the company to
cease and desist promoting its non-crush-resistant extended release
oxymorphone HCl product as A-B rated, or bio-equivalent, to the reformulated
OPANA ER. The lawsuit was filed earlier today, Tuesday, December 11, 2012.
As Endo reported in November, surveillance data collected by national
independent sources through the third quarter of 2012 suggest that the
introduction of reformulated OPANA ER designed to be crush-resistant in
February reduced abuse rates of the product when compared to the
non-crush-resistant version that Endo discontinued in May. Additionally, rates
of abuse for the non-crush-resistant 7.5mg and 15mg oxymorphone HCl tablets
marketed by Actavis appear to have increased more than 122 percent since Endo
launched its reformulated OPANA ER version.
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