Mallinckrodt, the pharmaceuticals business of
), recently received the clearance of the U.S. Food and Drug
Association (FDA) for the 32 mg strength of its Exalgo
(hydromorphone HCI) Extended-Release Tablets (CII). The tablet will
be available in the market within the next few weeks.
The FDA approval of the Exalgo 32 mg tablet marks a keystone for
Mallinckrodt. The tablet is meant for a specific set of
opioid-tolerant patients who suffer from tolerable to oppressive
chronic pain and stand in need of uninterrupted and continuous
opioid analgesia for a long time.
This newest offering is the intermediate dosage which provided
convincing results by counterpoising the patients during trials.
Per management, the approval of the tablet will enhance
Mallinckrodt's pain management portfolio and mount Covidien's
According to the company, the Exalgo tablets have a sizeable
market opportunity in the U.S. as statistics suggests that roughly
116 million Americans suffer from chronic pain. Despite the known
fact that opioid therapy is not the preferred choice of treatment
for all these individuals, it is of utmost clinical importance to
find the right dosage and treatment for these patients.
The extended-release pain medication Exalgo was launched in
2010. It uses the Oros drug delivery system with an inbuilt feature
to control the dispensation of the opioid analgesic. The Oros drug
delivery system will reduce fluctuations in blood plasma levels
while the new dosage will enhance the options available to a
physician at a stage before the right treatment plan for
opioid-tolerant patients is found.
Earlier, in March 2010, the FDA approved Mallinckrodt's 8, 12
and 16 mg Exalgo tablets. The company had submitted supplemental
New Drug Application (sNDA) for the 32 mg tablet in January 2012.
The application encompassed the conspectus of clinical trials as
well as post-marketing data validating the tolerance and
effectiveness of the Exalgo 32 mg tablet.
Mallinckrodt's strategy to enhance its operations and boost its
financial performance on the back of a solid product pipeline is
expected to yield positive results. Earlier this month, the company
revealed that it has inked an agreement with Xanodyne
Pharmaceuticals, an integrated specialty pharmaceutical company
with expertise in pain management.
Mallinckrodt is the largest provider of opioid pain management
drugs in the U.S. Exalgo and Pennsaid are its front-line branded
products, which are successfully contributing to the company's
sales. Covidien is looking to spin-off Mallinckrodt into a
stand-alone company by mid-2013.
Mallinckrodt upholds the initiatives to monitor the abuse,
misuse and overdose of opioid analgesics undertaken by the White
House Office of National Drug Control Policy. Recently, Covidien
also extended its support for the Sentinel Event Alert issued by
The Joint Commission regarding Safe Use of Opioids in
This particular issue provided a number of suggestions that can
be taken to avoid the risks associated with opioid use among
hospital in-patients. The company supported this initiative to
encourage safe and effective use of pain management drugs.
Covidien is a leading developer, manufacturer and distributor of
medical devices and services on a global scale. Its business
segments overlap with the business of its competitors such as
Becton, Dickinson and Company
Johnson and Johnson
CR Bard Inc
) among others.
While acquisitions remain the most important part of Covidien's
growth strategy, the approval underlines its aggressive strategy of
portfolio extension. It remains committed to rolling out new
products and technologies consistently. Management expects that
focus on product innovation and aggressive portfolio management
will enhance growth opportunities in the long run.
However, sustained pricing/procedure volume pressure,
fluctuating foreign exchange rates, and a sluggish U.S. and
European economy represent major headwinds.
We currently have a long-term 'Neutral' recommendation on
Covidien. The stock carries a Zacks #4 Rank, which translates into
a short-term Sell rating.
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