Financial details of the deal were not divulged but contract development and manufacturing organisation (CDMO) Recipharm said the addition of Altus’ abuse deterrent technologies will appeal to a lot of its customers.
“These include generic companies wishing to add differentiation to an existing extended release or immediate release product and branded companies seeking to enhance the value of a valuable portfolio product nearing the end of its patent life,” Carl-Johan Spak, EVP of Global Technologies, told this publication.
“FLEXITAB with its straightforward and cost-effective development and approval pathway also offers opportunities for both prescription and consumer products.”
According to Spak, the FLEXITAB platform is used in a number of globally commercialised products while the INTELLITAB technology has been selected by US pharma companies for the development of six extended release narcotic and stimulant products, the first of which will be soon be submitted for regulatory approval.
Under the terms of the license, Altus’ technology may be transferred to one or more Recipharm facilities.
Regulators and legislators are looking to stem the opioid abuse epidemic, which according to the Centers for Disease Control and Prevention caused the deaths of over 90 Americans daily in 2016 through overdose.
Solid dose prescription opioids have played a major part in this, due to their potential for abuse via oral, parental, nasal, or inhalation routes, and regulators and legislators.
Damon Smith, CEO, Altus Formulation, spoke with us about how his firm’s INTELLITAB tablet technology, comprising a combination of overlapping abuse deterrent features, can help deter inadvertent or deliberate misuse of a medication.
Chewing tablets represents the first level of medication abuse employed by would be non-medical drug users, he said, though this abuse can also occur inadvertently. The hardness of the INTELLITAB tablet formulations “can deter chewing and avoid tablet fracture,” he told us, which “has high value to deter new users and provides a safety feature to prevent inadvertent paediatric overdosing for example.”
Soaking, grinding, and snorting
A second level of medication abuse involves soaking or co-administration a tablet with alcohol, he continued.
“INTELLITAB tablets are impervious to alcohol and can reduce the rate of drug release when alcohol is present. Taking INTELLITAB tablets with alcohol is therefore not a route for an easy high.”
A third and more dangerous approach is intranasal insufflation of comminuted tablets – or grinding and snorting.
According to Smith, INTELLITAB tablets are designed to undergo sacrificial destruction under high stress to generate a complex debris that retains controlled release properties. “This complex debris is designed to make snorting difficult and unpleasant and to be non-rewarding by preventing rapid drug absorption across the nasal mucosa.”
The most dangerous method of drug abuse is the grinding, extraction and injection of a tablet, said Smith, but if an INTELLITAB tablet is crushed and mixed with a solvent, a solid gel forms rapidly to prevent extraction and impede loading of a syringe.