Collegium Pharmaceutical, Inc. Announces Positive Topline Results Of Human Abuse Potential Study Evaluating Intranasal Administration Of Crushed Oxycodone DETERx®, An Abuse-Deterrent, Extended-Release Product

CANTON, MA--(Marketwired - January 15, 2014) - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, today announced positive topline results from a human abuse potential (HAP) study for Oxycodone DETERx®, it’s extended-release (ER), abuse-deterrent, oxycodone microsphere-in-capsule product. Oxycodone DETERx®, utilizing Collegium’s DETERx® technology, is designed to be more resistant to tampering and abuse than traditional formulations of the drug and is currently in Phase 3 clinical development. The product’s abuse-deterrent characteristics are being evaluated in laboratory and clinical studies, consistent with the recently-issued FDA Guidance “Abuse-Deterrent Opioids - Evaluation and Labeling.”

In a recently completed study, intranasal administration of crushed Oxycodone DETERx® was compared with oral administration of intact Oxycodone DETERx® and with intranasal administration of crushed immediate-release (IR) oxycodone in non-dependent, recreational opioid users (n=36). The primary endpoint for the study was drug liking, measured up to 24 hours after dosing using a bipolar visual analogue scale (VAS). Oxycodone DETERx® (both crushed intranasal and intact oral) had significantly lower peak “drug liking” (Emax) when compared with intranasal crushed IR oxycodone (p < 0.0001). Furthermore, when comparing Oxycodone DETERx treatments, Emax for “drug liking” after administration of crushed intranasal Oxycodone DETERx® was significantly lower than for intact oral administration of DETERx® (p < 0.05).

Prescription opioids are critical in the management of moderate-to-severe chronic pain. ER formulations of opioids contain high doses of active drug in order to maintain the analgesic effect over a prolonged dosing interval. Abusers frequently tamper with these formulations in an attempt to subvert the time-release mechanism and access the entire drug load at once. Many conventional ER formulations are susceptible to tampering techniques such as breaking, crushing, or chewing. Crushed ER formulations can then be used intranasally to achieve high plasma concentrations and maximum euphoric effects. Oxycodone DETERx® has been developed to provide clinicians and patients with a novel abuse-deterrent formulation of oxycodone utilizing the DETERx® technology. HAP studies are clinical studies that determine the intrinsic potential for abuse of a drug formulation. These studies are conducted in a non-dependent, recreational drug abuser population and are designed to predict how probable it is that a particular drug formulation will be attractive to abusers (i.e., “liked”). The primary measure in this study, drug liking, is recommended by the FDA in the Guidance for pre-marketing evaluation of abuse-deterrent opioid formulations. This measure is known to correlate most directly with a drug’s potential for abuse.

“There is a significant societal need for safer and more abuse-deterrent analgesics,” said Dr. Lynn Webster, Vice President Scientific Affairs, PRA International. “Oxycodone DETERx® demonstrated significantly reduced drug liking, the primary endpoint, when compared to intranasal crushed IR oxycodone. This is the first study that I am aware of that demonstrates reduced liking of nasal administration when compared with its intended oral administration.”

Statistically significant differences in peak effects (Emax) between Oxycodone DETERx® treatments (crushed intranasal and intact oral) and crushed IR oxycodone intranasal were also demonstrated for secondary endpoints including “feeling high,” “any drug effects,” “good drug effects,” and the Addiction Research Center Inventory - Morphine Benzedrine Group (ARCI-MBG) score (a measure of euphoria and positive mood).

“We are very excited about the results of this study as they are consistent with prior findings that demonstrate that Oxycodone DETERx® may provide unique advantages when compared with currently marketed products as well as those in development,” said Michael Heffernan, CEO of Collegium. “We are completing enrolment in our Phase 3 program and remain on track to file our NDA in 2014.”

Additional Study Results

• For measures including “Overall Drug Liking,” “Take Drug Again,” and “Price Value Assessment,” intranasal crushed Oxycodone DETERx® was rated significantly lower than intranasal IR oxycodone and did not differ statistically from placebo.

• The secondary measure of “bad drug effects” was numerically highest for intranasal crushed Oxycodone DETERx®.

• The mean peak plasma concentration (Cmax) following intranasal administration of crushed Oxycodone DETERx® capsule contents was significantly lower than for crushed IR oxycodone administered by the intranasal route. The median time to reach peak plasma concentration (Tmax) was substantially longer for crushed Oxycodone DETERx® capsule contents than for crushed IR oxycodone.

• The Cmax following intranasal administration of the crushed Oxycodone DETERx® capsule contents was also lower than the mean Cmax observed for the intact capsule administered orally; both treatment groups had an equivalent median Tmax.

Study Design

Randomized, double-blind, double-dummy, positive- and placebo-controlled, single-dose, 4-treatment, 4-period crossover comparison study designed to evaluate the abuse potential and pharmacokinetics of crushed 40 mg Oxycodone DETERx® intranasal, intact 40 mg of Oxycodone DETERx® oral, and crushed 40 mg of IR oxycodone intranasal. The primary comparison of interest was between the crushed 40 mg Oxycodone DETERx® intranasal and crushed 40 mg of IR oxycodone intranasal.

About DETERx® Technology

The DETERx® drug delivery platform consists of a microsphere-in-capsule formulation. While developed primarily to provide abuse-deterrent properties to protect against common methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the multi-particulate design is expected to enable patients with difficulty swallowing to open the capsule and to administer the contents sprinkled onto food, directly into the mouth or via a gastrostomy tube, while maintaining the ER properties of the product. The DETERx® technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows that would benefit from protection against misuse such as breaking, crushing, grinding, or dissolving the product. The formulation platform is covered by U.S. and international patents and patent applications. Oxycodone DETERx® is the first of a number of product candidates using the DETERx® platform.

About Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx® formulation platform for the treatment of chronic pain. The DETERx® oral drug delivery technology provides ER delivery, unique abuse-deterrent properties, and flexible dose administration options. For more information, visit the Company’s website at www.collegiumpharma.com.