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Orexo AB has operations in Sweden and the United States. Operations are monitored and presented in the segments USA Pharma, Digital Therapeutics (DTx), and HQ & Pipeline. The majority is from the USA Pharma segment. Geographically, the majority is derived from the United States. USA Pharma includes the commercialization of fully owned pharmaceuticals in the United States market. Digital Therapeutics include the commercialization of Orexo's groundbreaking evidence-based digital therapeutics, mainly in the United States market, which is in an early development stage. HQ &Pipeline includes the Development of pharmaceuticals performed at Orexo's headquarters in Uppsala, Sweden.

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The FDA warned patients and prescribers about the risk of potential dental problems arising from the us

Using Opioid Addiction Drug Buprenorphine May Cause Dental Issues, FDA Flags

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FDA Approves Zubsolv for Maintenance Treatment of Opioid Dependence 

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The&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-risks-dental-problems-associated-buprenorphine-medicines-dissolved-mouth-treat" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA warned patients and prescribers</a>&nbsp;about the risk of potential dental problems arising from the use of buprenorphine medicines to treat opioid addiction and pain.

<ul>
	<li>The agency said the opioid addiction treatment had been reported to cause tooth decay, infection, and, in some cases, total tooth loss in patients with no history of dental issues.</li>
	<li>The buprenorphine medicines that are associated with dental problems are tablets dissolved under the tongue and films placed against the inside of the cheek.</li>
	<li>The FDA approved buprenorphine as a tablet in 2002 and as a film in 2015.</li>
	<li>It said patients might lessen their risk by taking preventative measures.</li>
	<li>After the product is completely dissolved, patients should take a large sip of water, swish it gently around their teeth and gums, and swallow, waiting for at least one hour before brushing their teeth after using the product to avoid damage to the teeth.</li>
	<li>The regulator&#39;s approved buprenorphine products include&nbsp;Orexo AB&#39;s&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/orxof#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ORXOF</a>) Zubsolv and&nbsp;Indivior Plc&#39;s&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/invvy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">INVVY</a>) Suboclade.</li>
</ul>

Orexo U.S (OTC: <a class="ticker" href="/stock/orxof#OTC">ORXOF</a>) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII).&nbsp;Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and&hellip;Orexo U.S (OTC: <a class="ticker" href="/stock/orxof#OTC">ORXOF</a>) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII).&nbsp;Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with higher bioavailability, a fast dissolve time, smaller tablet size and a new menthol flavor.

Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.i,ii,iii Although it is a treatable condition, about 60 percent of opioid dependent patients in the U.S. do not receive treatment.iii Every year thousands of patients continue to misuse opioids rather than risk public exposure by receiving treatment.iv


 
 <a href="http://www.benzinga.com/pressreleases/13/07/n3730901/u-s-fda-approves-zubsolv-for-the-maintenance-treatment-of-opioid-depend">See full press release</a>

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