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Pear Therapeutics Receives Safer Technologies Program (STeP) Designation from FDA for Product Candidate to Treat Acute and Chronic Pain

Pear Therapeutics Receives Safer Technologies Program (STeP) Designation from FDA for Product Candidate to Treat Acute and Chronic Pain

Boston, April 13, 2022– (BUSINESS WIRE) – Pear Therapeutics, Inc. (Nasdaq: PEAR), the leading developer and marketer of software-based drugs called digital prescription therapies (PDTs)And Today it announced that it has received Safer Technologies Program (STeP) designation for medical devices from the US Food and Drug Administration (FDA) for Pear-010, a candidate product designed for the treatment of acute and chronic pain.

Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention (virtual reality relieves pain) for patients 18 years of age or older who experience acute postoperative pain following surgery. The candidate product is designed to reduce acute postoperative and postoperative pain, analgesics (eg, opioids) used for postoperative urinary retention, postoperative ileus, or advanced unintended postoperative sedation and respiratory depression.

With more than 50 million patients in the United States experiencing pain, it is among the most common and costly acute and chronic conditions, and is estimated to result in up to $635 billion in annual health care expenditures, disability and lost productivity.1,2 Overdependence on opioid-based treatments has led to significant adverse events and a nationwide epidemic of opioid misuse and diversion.3-6 Effective pain management is an important factor in reducing the length of hospital stay and improving outcomes for medical and surgical patients, including their readmission risk.7-11

“We believe that pain is well suited to treatment with PDT because currently more than 50 million patients are left to choose between pain and opioid treatment,” said Yuri Maric, Pear’s chief medical officer. “We commend the Food and Drug Administration for recognizing the need to help patients obtain timely treatments for conditions such as pain.”

Pear intends to use the PearCreate™ platform to develop the Pear-010. PearCreate is the company’s discovery and development platform.

The Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination products that can reasonably be expected to significantly improve the safety of currently available treatments or diagnoses. The goal of the STeP is to provide patients and healthcare providers with timely access to these medical devices by accelerating their development, evaluation and review, while maintaining legal standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the mission Food and Drug Administration to Protect and Promote Public Health. STeP participation does not imply product license. Pear-010 has not received marketing authorization from the Food and Drug Administration and is not available for sale in the United States.

About pear treatment

Pear Therapeutics, Inc. Pear, which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), and Pear Corporation is the leading developer and marketer of software-based drugs, called digital prescription therapies (PDTs). Pear aims to redefine care through the widespread use of clinically approved program-based therapies to provide better patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first comprehensive platform for discovery, development, and delivery of PDTs to patients and a pipeline of products and filters across therapeutic domains, including the first of three PDTs with disease treatment claims from the Food and Drug Administration. Pear product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the U.S. Food and Drug Administration to treat the disease. The second pear product, reSET-O®For the treatment of opioid use disorder, it was the first PDT to receive a breakthrough rating. The third pear product, Somryst® For the treatment of chronic insomnia, PDT was first introduced through the FDA’s traditional 510(k) pathway while simultaneously reviewed by the FDA’s Program Accreditation Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

Forward-looking statements from pear remedies

Certain statements and expectations in this press release may be considered forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally relate to, or involve, future events of, or the future performance of Pear. For example, the statement that pain is well suited to treatment with PDT is a forward-looking statement. In some cases, you may identify forward-looking statements by terms such as “may,” “will,” “intend,” “estimate,” “expect,” “believe,” “continue,” or the negatives or variations of these terms or expressions. similar. These forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

These forward-looking statements are based on estimates and assumptions that are inherently uncertain, although considered reasonable by Pear and its management. Factors that could cause actual results to differ materially from current expectations include, but are not limited to: (i) Pear-010 may not receive FDA authorization in a timely manner, or at all, (ii) delay or reluctance by patients and/or service providers to adopt, order, or use Pear products, (iii) the potential for Pear to be adversely affected by other economic, commercial, regulatory, and/or competitive factors; (iv) Evolution of markets in which pears compete. (5) the impact of the COVID-19 pandemic on Pear’s business; (6) changes in applicable laws or regulations; and (vii) other risks and uncertainties set forth in Pear’s future filings with the Securities and Exchange Commission. These filings will identify and address other significant risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Readers are cautioned not to place undue reliance on forward-looking statements, and Pear assumes no obligation and does not intend to update or revise such forward-looking statements, whether as a result of new information, future events or otherwise. The pear does not give any assurance that the pear will fulfill its expectations. The inclusion of any statement in this communication does not constitute an admission by Pear or any other person that the events or circumstances described in this statement are material.

References:

  1. https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm#:~:text=An%20estimated%2020.4%25%20(50.0%20million,adults%2C%20adults%20living%20in %20 poverty %2c

  2. Gaskin DJ, Richard B. The economic costs of pain in the United States. J pain. (2012) 13: 715-24. doi: 10.1016/j.jpain.2012.03.009

  3. Herzig SJ, Rotberg MB, Cheong M, Ngo LH, Marcantonio Air. Opioid use and opioid-related adverse events in non-surgical patients in US hospitals. J Hosp Med. February 2014; 9 (2): 73-81.

  4. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and mortality associated with opioid overdose. Gamma. 6 April 2011; 305 (13): 1315-1321.

  5. Manchikanti L, Helm S, 2nd, Fellows B, et al. The opioid epidemic in the United States. Pain doctor. July 2012; 15 (3 Supplement): ES9-38.

  6. Manchikanti L, Abdi S, Atluri S et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for prescribing responsible opioids in chronic non-cancerous pain: Part I – Evaluation of the evidence. Pain doctor. July 2012; 15 (3 Supplement): S1-65.

  7. Morrison RS, Magaziner J, Gilbert M, et al. Relationship between pain and opioid analgesics on the development of delirium after hip fracture. J Gerontol A Biol Sci Med Sci. Jan 2003; 58 (1): 76-81.

  8. Allen Liles E, JK, MG, M A. Hospital management of vascular occlusive pain crisis in patients with sickle cell disease using the care pathway. Hospital practice. 2014; 42: 70-76.

  9. Epstein A, Crosby C, Martin S, et al. Readmissions of 30 days or earlier for gastrointestinal medical oncology patients after discharge from inpatient service at a cancer center: characteristics and potential for prevention. Hospital practice. 1995; 42:34-44.

  10. Cooley KC, Williams PA, Dabbous SV, Chen C, Smith RB. Retrospective evaluation of unexpected admissions and readmissions after same-day surgery and associated costs. J Clin Inst. August 2002; 14 (5): 349-353.

  11. Elixhauser A, Steiner C. Re-admission to US Hospitals by Diagnostic, 2010. Health Care Research Agency and Quality Statistical Brief. 2013; No. 153.

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Contacts

Media and Investors:
Mira Murphy
Senior Director of Corporate Communications
[email protected]

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